clinical research professional

University Of Cincinnati

<p></p><div><p><b>Current UC employees must apply internally via </b><b><i>SuccessFactors</i></b></p><div></div><p><b><br>
Next Lives at the University of Cincinnati</b></p><p></p><div><br>
Founded in 1819, the University of Cincinnati ranks among the nation&rsquo;s best urban public research universities. Home to more than 53,600 students, 12,000 faculty and staff, and over 360,000 living alumni, UC, a Carnegie 1 institution, combines research prowess with a physical setting The New York Times has called &ldquo;the most ambitious campus design program in the country.&quot; UC's momentum has never been stronger as the anchor of the Cincinnati Innovation District, the oldest cooperative education (co-op) program in the country with students earning $94 million annually through paid experiences, an academic health system, and as a member of the Big 12 Conference. The university contributes $10.6 billion in economic impact to the city and $22.7 billion to the state of Ohio. At UC, next is all of us. Learn more at uc.edu.</div><div></div><div><br>
UC is a mission-driven organization where we are committed to student success and positively transforming the community through scholarship and service. We thrive on innovation, making an impact, and fostering an environment where staff and faculty are key contributors to UC&rsquo;s success.</div><div></div><div><br>
</div><div><div><div><h2 class="jobSectionHeader"><b>Job Overview</b></h2></div><div><p>
As one of the oldest medical schools in the country, the University of Cincinnati College of Medicine (COM) has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients. In partnership with the UC Health academic healthcare system and Cincinnati Children&rsquo;s Hospital Medical Center, College of Medicine&rsquo;s faculty are transforming the world of medicine every day. The Department of Internal Medicine is a top-tier department with a world-renowned faculty and staff.</p><p></p><p><br>
One full-time Clinical Research Professional (CRP) staff position is available in the Division of Pulmonary, Critical Care and Sleep Medicine. This position may be CRP I, CRP II, or CRP III as the level of the position will depend on the candidate&rsquo;s education and experience. Duties can span a broad range of activities or be primarily focused within one or more areas of the clinical research spectrum.</p><p></p><p><b><br>
Clinical Research Professional I</b></p><p>
Provide technical support and assistance for a designated department, program, or central unit. Duties can span a broad range of activities or be primarily focused within one or more areas of the clinical research spectrum.</p><p></p><p><b><br>
Clinical Research Professional II</b></p><p>
Plan, evaluate, coordinate and/or manage elements of multiple or complex clinical research projects for a designated department, program, or central unit. Duties can span a broad range of activities or be primarily focused within one or more areas of the clinical research spectrum.</p><p></p><p><b><br>
Clinical Research Professional III</b></p><p>
Design, evaluate, coordinate and/or manage elements of multiple or complex clinical research projects for a designated department, program, or central unit. Duties can span a broad range of activities or be primarily focused within one or more areas of the clinical research spectrum.</p></div></div><p></p><div><div><h2 class="jobSectionHeader"><b><br>
Essential Functions</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>
Clinical Research Professional I</b></h2></div><div><ul><li>
Plan and coordinate clinical research projects.</li><li>
Screen patients for admittance in study based on pre-determined criteria.</li><li>
In conjunction with the investigator, document and evaluate adverse events and response to treatment.</li><li>
Coordinate the generation of data for proposals, reports, and manuscripts. Assist in development of reports.</li><li>
Perform routine physical/clinical procedures.</li><li>
Ensure compliance with contract principles, federal regulations, laws and University of Cincinnati (UC)/University of Cincinnati Physicians Company (UCPC) policy and operating procedures.</li><li>
Maintain regulatory documentation. Prepare IRB submissions.</li><li>
Draft subject informed consents and consent comprehension tests. Assist in drafting compliant advertisements.</li><li>
Liaison with medical staff, university departments, ancillary departments, satellite facilities, IRB, and industry contacts.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Clinical Research Professional II</b></h2></div><div><ul><li>
Provide direction, instruction and guidance to coordinate research activities, including patient screening and recruitment, enrollment and education. Ensure protocol procedures have been completed adhering to Good Clinical Practice Guidelines as defined by the Federal Drug Administration (FDA) and serve as subject matter expert.</li><li>
Collaborate with care coordinators, social workers, psychologists, physicians and other appropriate treatment team members in diagnostic formulation, treatment direction, and recommendations. Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.</li><li>
Assist with developing and revising policies and procedures for the research team to ensure compliance with the protocol.</li><li>
Serve as a resource within the department for the development of less experienced team members.</li><li>
Contribute to the development of new processes, procedures, tools and training to enhance clinical research activities, compliance, and efficiency.</li><li>
Ensure compliance with contract principles, federal regulations, laws and University of Cincinnati/University of Cincinnati Physicians Company (UCPC) policy and operating procedures.</li><li>
Perform related duties based on departmental need. This job description can be changed at anytime.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Clinical Research Professional III</b></h2></div><div><ul><li>
Provide direction, instruction and guidance to coordinate research activities including patient screening and recruitment, enrollment and education. Ensure protocol procedures have been completed adhering to Good Clinical Practice Guidelines as defined by the Federal Drug Administration (FDA) and serve as subject matter expert.</li><li>
Independently coordinate nursing/social work and patient care and/or patient follow-up functions of the clinical study including planning and developing related activities. Provide quality patient care to patients and their families within area of clinical specialty.</li><li>
Collaborate with care coordinators, social workers, psychologists, physicians and other appropriate treatment team members in diagnostic formulation, treatment direction, and recommendations. Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.</li><li>
Initiate and assist with developing and revising policies and procedures for nursing practice.</li><li>
Serve as a peer-mentor within the department, supporting management and in various responsibilities as appropriate including the development of less experienced team members.</li><li>
Contribute to the development of new processes, procedures, tools and training to enhance clinical research activities, compliance, and efficiency.</li><li>
Ensure compliance with contract principles, federal regulations, laws and University of Cincinnati/University of Cincinnati Physicians Company (UCPC) policy and operating procedures.</li><li>
Perform related duties based on departmental need. This job description can be changed at any time.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Required Education</b></h2></div><div><p><b>
Clinical Research Professional I</b></p><ul><li>
Bachelor&rsquo;s Degree must be in a related field.</li><li>
Five (5) years of relevant education, experience and/or other specialized training can fulfill minimum education and experience requirements</li></ul><p></p><p><b><br>
Clinical Research Professional II</b></p><ul><li>
Bachelor&rsquo;s Degree must be in a related field.</li><li>
Seven (7) years of relevant education, experience and/or other specialized training can fulfill minimum education and experience requirements</li></ul><p></p><p><b><br>
Clinical Research Professional III</b></p><ul><li>
Bachelor's Degree must be in a related field.</li><li>
Nine (9) years of relevant education, experience and/or other specialized training can fulfill minimum education and experience requirements</li></ul></div></div><p></p><div><div><h2 class="jobSectionHeader"><b><br>
Required Experience</b></h2></div><div><div><b>
Clinical Research Professional I</b></div><ul><li>
One (1) year of related experience.</li></ul><div></div><div><b><br>
Clinical Research Professional II
</b></div><ul><li>Three (3) years relevant experience</li></ul><div></div><div><b><br>
Clinical Research Professional III</b></div><ul><li>
Five (5) years of relevant experience</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Required Trainings/Certificates</b></h2></div><div><p><b>
Clinical Research Professional III</b></p><ul><li>
SoCRA/ACRP/RAPS certification</li><li>
For patient facing role, CPR certification</li></ul></div></div><p></p><div><div><h2 class="jobSectionHeader"><b><br>
Additional Qualifications Considered</b></h2></div><div><p><b>
Clinical Research Professional I and II</b></p><ul><li>
Experience in an academic or clinical setting in the area of clinical specialization.</li></ul><p></p><p><b><br>
Clinical Research Professional III</b></p><ul><li>
Master&rsquo;s Degree</li><li>
Experience in an academic or clinical setting in the area of clinical specialization.</li></ul></div></div><p></p><div><div><h2 class="jobSectionHeader"><b><br>
Physical Requirements/Work Environment</b></h2></div><ul><li>
Office environment/no specific unusual physical or environmental demands.</li></ul></div></div><p></p><p><b><br>
Compensation and Benefits</b></p><p></p><p><br>
UC offers an exceptional benefits package designed to support your well-being, financial security, and work-life balance. (UC Benefits) Eligibility may vary by position and FTE status. Highlights include:</p><p></p><p><br>
Salary/Hourly Pay Rate Information:</p><p></p><p><b><br>
Comprehensive Tuition Remission</b></p><p>
UC provides tuition remission for you and your eligible dependents, covering tuition costs for nearly all undergraduate and graduate programs offered by the university.</p><p></p><p><b><br>
Robust Retirement Plans</b></p><p>
As a UC employee, you won&rsquo;t contribute to Social Security (except Medicare). Instead, you&rsquo;ll choose between state pension plans (OPERS, STRS) or an Alternative Retirement Plan (ARP), with UC contributing 14&ndash;18% of your salary based on position.</p><p></p><p><b><br>
Real Work-Life Balance</b></p><p>
UC prioritizes work-life balance with a generous time-off policy, including:</p><p>
Vacation and sick time</p><p>
11 paid holidays and additional end-of-year paid time off (Winter Season Days)</p><p>
6 weeks of paid parental leave for new parents</p><p></p><p><b><br>
Additional Benefits Include:</b></p><ul><li>
Competitive salary based on experience</li><li>
Comprehensive health coverage (medical, dental, vision, prescription)</li><li>
Flexible spending accounts &amp; wellness programs</li><li>
Professional development &amp; mentorship opportunities</li></ul><p></p><p><br>
To learn more about why UC is a great place to work, please visit our Careers Page.</p><p></p><p><br>
UC is an E-Verify employer. If hired into this position, you will be required to provide satisfactory proof of employment eligibility by providing acceptable, original forms of identification for employment verification via the Federal I-9 employment verification process. Click here for a list of acceptable documents.</p><p><br>
</p><p><b>Important</b>: To apply you must create a profile and submit a complete job application through the UC applicant portal. We are unable to consider &ldquo;easy apply&rdquo; applications submitted via other websites. For questions about the UC recruiting process or to request accommodations with the application, please contact UC HR at jobs@uc.edu.</p><p></p><p><b><br>
Equal Opportunity Employer. Building a workplace where all qualified applicants will receive consideration for employment, including Individuals with Disabilities and Protected Veterans.</b></p><p></p><p><br>
REQ: 101992</p></div>

Clinical Research Professional (I, II or III) Department of Internal Medicine, Division of Pulmonary

Advanced Dermatology and Cosmetic Surgery

SUMMARY
<br>The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the supervision of the clinical Principal Investigator (PI). The CRC reports directly to the Director of Clinical Research. While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
<br><br>
<b>ESSENTIAL DUTIES AND RESPONSIBILITIES:</b><br>
<ul>
<li>Coordinates with Principal Investigator, department, and administration to help ensure that clinical research and related activities are performed in accordance with Federal Regulations and sponsoring agency (pharmaceutical and or CRO) policies and procedures.</li>
<li>Assists the PI in study feasibility assessments as requested.</li>
<li>Reviews and comprehends the protocol.</li>
<li>Attends investigator meetings as required or requested by the PI.</li>
<li>Collaborates with the PI to prepare Institutional Review Board (IRB) and any other regulatory submission documents as required by the protocol.</li>
<li>Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs and temperature logs.</li>
<li>Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.</li>
<li>Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.</li>
<li>Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.</li>
<li>Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).</li>
<li>Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.</li>
<li>Conducts or participates in the informed consent process including interactions with the (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.</li>
<li>Develop advertising and other informational materials to be used in subject recruitment.</li>
<li>Identifies and calls possible subjects for recruitment, schedules appointments for study visits, maintains enrollment logs and sends them to study sponsor or CRO.</li>
<li>Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.</li>
<li>Coordinates participant tests and procedures, draws blood or collects urine sample for laboratory testing as specified by the protocol. Prepares the specimens for shipping to laboratory.</li>
<li>Collects data and preforms assessments specified in the protocol; vitals, questionnaires, EKG, photos. Assures timely completion of Case Report Forms.</li>
<li>Maintains study timelines.</li>
<li>Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol on Investigational Drug/Device Accountability. Dispenses study drug to study patients.</li>
<li>Completes study documentation and maintains study files in accordance with sponsor requirements including, but not limited to, consent forms, source documentation, and note to file, case report forms, and investigational material accountability forms.</li>
<li>Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.</li>
<li>Retains all study records in accordance with sponsor requirements in Regulatory binder</li>
<li>Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.</li>
<li>Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, and the sponsoring agency in accordance with Federal regulations and policies and procedures.</li>
<li>Arranges secure storage of study documents that will be maintained according to the contracted length of time, whichever is longer.</li>
</ul>
KNOWLEDGE, SKILLS, AND ABILITIES
<br><ul>
<li>Knowledge of ADCS policies, including quality assurance policies and applicable government regulations and standards, and the ability to actively apply that knowledge in the performance of all job duties</li>
<li>Knowledge of electronic health record access-level privileges and responsibilities, and the ability to perform electronic health record job duties for this position within the parameters of the access level assigned</li>
<li>Ability to practice confidentiality and follow HIPAA regulations with patient information</li>
<li>Ability to practice professional ethics and use discretion concerning ADCS directives and proprietary information/trade secrets of the organization</li>
<li>Ability to recognize a problem and effectively problem-solve, using guidance from the provider and/or management when necessary</li>
<li>Knowledge of medical terminology and ability to use appropriately</li>
<li>Ability to manage time efficiently, prioritize, multi-task, and adapt to change</li>
<li>Ability to maintain high level of accuracy in all documentation and in the performance of all job duties</li>
<li>Ability to perform the essential job duties within the scope of education and training</li>
<li>Skilled in typing/keyboarding; skilled in using computers</li>
</ul>
PROFESSIONALISM
<br><ul>
<li>Project a professional manner and image, including proper workplace attire and grooming standards; exhibit professional conduct at all times.</li>
<li>Adhere to ethical principles and core ADCS values; follow all ADCS policies</li>
<li>Treat all patients and staff with respect, compassion, and empathy, recognizing and respecting cultural diversity</li>
<li>Demonstrate initiative and responsibility for actions</li>
<li>Work as an effective team member</li>
<li>Maintain a strong record for attendance and punctuality in arriving at work</li>
<li>Enhance skills through continuing education</li>
</ul>
EDUCATION
<br>Bachelor's degree in a related field preferred but not required
<br>LICENSURE/CERTIFICATION REQUIREMENTS
<br><ul>
<li>Clinical Research Coordinator (CRC) or Clinical Research Professional (CRP) Certification from SoCRA or ACRP</li>
<li>Good Clinical Practice (GCP) preferred</li>
<li>International Air Transport Association (IATA) Training preferred</li>
</ul>
LANGUAGE/COMMUNICATION REQUIREMENTS
<br><ul>
<li>Ability to read and interpret work-related documents such as reports, communications, safety rules, operating and maintenance instructions, and procedure manuals</li>
<li>Ability to write routine reports and correspondence</li>
<li>Ability to listen, speak, and interact effectively with all patients and co-workers, adapting communication for optimal understanding</li>
<li>Ability to practice professional telephone etiquette and techniques on all calls</li>
</ul>
MATHEMATICAL SKILLS
<br>The ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
<br>REASONING ABILITY
<br>Ability to understand and follow instructions, both written and verbal. Must possess strong problem identification/resolution skills and be able to manage complications involving several variables.
<br>WORK ENVIRONMENT AND CONDITIONS
<br>Work is performed in offices and occasionally research sites. Involves frequent telephone and in-person contact with staff, vendors, providers, and management. Requires some flexibility in working hours. Requires the ability to work in a demanding environment and to effectively resolve conflicts as they arise. Occasional weekend work required. Occasional travel required.
<br>COMPENSATION
<br><ul>
<li>401K/PTO/Vacation/Benefit Packages</li>
</ul>
<b>NOTE:</b> This job description may not include all duties assigned to the employee and may be updated and modified by Management, without notice, according to operations at any given time.

Clinical Research Coordinator - National Harbor, MD

Headlands Research

<div><div><p>At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion.</p></div><br>
<p></p>
<h1 class="jobSectionHeader"><b>
Clinical Research Coordinator (CRC)</b></h1>
<p>
 <b>Location:</b> Pikesville, MD | Site Name: Headlands Research - Pharmasite | Full-Time</p><br>
<p></p>
<p>
Are you an experienced clinical research professional with a passion for advancing medicine? Join a leading, integrated clinical research network dedicated to high-quality data, patient-centered care, and innovation in clinical trials.</p>
<p>
We're seeking a <b>Clinical Research Coordinator (CRC)</b> for our clinical research site located in Pikesville, MD. The CRC will manage and execute Phase I-IV clinical studies in accordance with FDA regulations, GCP/ICH guidelines, and sponsor protocols. This role is ideal for someone who thrives in a fast-paced environment and is eager to make an impact in the clinical research industry.</p>
<p><b>
Type:</b> Regular Full-time Employee<br>
<b>Schedule:</b> Mondays through Fridays, 8:00am - 5:00pm<br>
<b>Location:</b> Onsite in Pikesville, MD (no capabilities for remote or hybrid work)<br>
<b>Reports to:</b> Site Director<br>
<b>Benefits:</b> Our benefits package for full-time employees includes health insurance (medical, dental, and vision), Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA), Paid Time Off (PTO), a variety of disability, accident, and life insurance options, as well as many more.</p>
<h2 class="jobSectionHeader"><b>
 </b><b>What We Offer</b></h2>
<ul><li>Competitive pay + annual performance incentives</li>
<li>Medical, dental, and vision insurance</li>
<li>401(k) plan with company match</li>
<li>Paid time off (PTO) and company holidays</li>
<li>A mission-driven culture focused on advancing medicine and improving patient outcomes</li></ul><br>
<p></p>
<p></p>
<h2 class="jobSectionHeader"><b> </b><b>Why Join Us?</b></h2>
<p>
You'll be part of a growing, mission-driven organization that values its people. At our core, we're committed to bringing innovative medical treatments to patients faster&mdash;while creating an environment where employees thrive. If you're passionate about clinical research and ready to make a difference, we'd love to hear from you.</p><br>
<p></p>
<p><b>
Responsibilities:</b></p>
<ul>
<li>Coordinate all aspects of assigned clinical trials from site initiation to study close-out</li>
<li>Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards</li>
<li>Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs</li>
<li>Manage subject recruitment, informed consent, and retention strategies</li>
<li>Ensure timely data entry and resolution of EDC queries</li>
<li>Report and follow up on all adverse events, serious adverse events, and deviations</li>
<li>Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders</li>
<li>Prepare for and participate in monitoring visits, audits, and inspections</li>
<li>Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems</li>
<li>Execute study procedures such as phlebotomy, ECGs, and sample processing within scope (as trained)</li>
<li>Attend investigator meetings and provide cross-functional support as needed</li>
<li>Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control</li></ul><br>
<p></p>
<p><b>
Requirements:</b></p>
<ul>
<li>Bachelor's degree OR 2 years of college in a health-related program OR experience and training in conducting clinical trials with knowledge of ICH GCP required OR licensed as a Licensed Practical Nurse (LPN) or higher</li>
<li>Previous experience as a Clinical Research Coordinator preferred</li>
<li>Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures</li>
<li>Proficiency in medical terminology and clinical documentation practices</li>
<li>Strong interpersonal, verbal, and written communication skills</li>
<li>Organized, detail-oriented, and capable of managing multiple priorities</li>
<li>Proficient in Microsoft Office and other clinical research systems</li></ul><br>
<p></p>
<p>
 <b>Apply now</b> to become a part of a team that's changing the future of healthcare&mdash;one trial at a time.</p></div><p></p>

Clinical Research Coordinator

<div><div><p>At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion.</p></div><p></p><div><br>
<h1 class="jobSectionHeader"><b>
Clinical Research Coordinator (CRC)</b></h1>
<p>
<b>Location:</b> Pikesville, MD | Site Name: Headlands Research - Pharmasite | Full-Time</p><br>
<p></p>
<p>
Are you an experienced clinical research professional with a passion for advancing medicine? Join a leading, integrated clinical research network dedicated to high-quality data, patient-centered care, and innovation in clinical trials.</p>
<p>
We&rsquo;re seeking a <b>Clinical Research Coordinator (CRC)</b> for our clinical research site located in Pikesville, MD. The CRC will manage and execute Phase I-IV clinical studies in accordance with FDA regulations, GCP/ICH guidelines, and sponsor protocols. This role is ideal for someone who thrives in a fast-paced environment and is eager to make an impact in the clinical research industry.</p>
<p><b>
Type:</b> Regular Full-time Employee<br>
<b>Schedule:</b> Mondays through Fridays, 8:00am - 5:00pm<br>
<b>Location:</b> Onsite in Pikesville, MD (no capabilities for remote or hybrid work)<br>
<b>Reports to:</b> Site Director<br>
<b>Benefits:</b> Our benefits package for full-time employees includes health insurance (medical, dental, and vision), Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA), Paid Time Off (PTO), a variety of disability, accident, and life insurance options, as well as many more.</p>
<h2 class="jobSectionHeader"><b>
</b><b>What We Offer</b></h2>
<ul><li>Competitive pay + annual performance incentives</li>
<li>Medical, dental, and vision insurance</li>
<li>401(k) plan with company match</li>
<li>Paid time off (PTO) and company holidays</li>
<li>A mission-driven culture focused on advancing medicine and improving patient outcomes</li></ul><br>
<p></p>
<p></p>
<h2 class="jobSectionHeader"><b>Why Join Us?</b></h2>
<p>
You&rsquo;ll be part of a growing, mission-driven organization that values its people. At our core, we&rsquo;re committed to bringing innovative medical treatments to patients faster&mdash;while creating an environment where employees thrive. If you&rsquo;re passionate about clinical research and ready to make a difference, we&rsquo;d love to hear from you.</p><br>
<p></p>
<p><b>
Responsibilities:</b></p>
<ul>
<li>Coordinate all aspects of assigned clinical trials from site initiation to study close-out</li>
<li>Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards</li>
<li>Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs</li>
<li>Manage subject recruitment, informed consent, and retention strategies</li>
<li>Ensure timely data entry and resolution of EDC queries</li>
<li>Report and follow up on all adverse events, serious adverse events, and deviations</li>
<li>Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders</li>
<li>Prepare for and participate in monitoring visits, audits, and inspections</li>
<li>Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems</li>
<li>Execute study procedures such as phlebotomy, ECGs, and sample processing within scope (as trained)</li>
<li>Attend investigator meetings and provide cross-functional support as needed</li>
<li>Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control</li></ul><br>
<p></p>
<p><b>
Requirements:</b></p>
<ul>
<li>Bachelor's degree OR 2 years of college in a health-related program OR experience and training in conducting clinical trials with knowledge of ICH GCP required OR licensed as a Licensed Practical Nurse (LPN) or higher</li>
<li>Previous experience as a Clinical Research Coordinator preferred</li>
<li>Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures</li>
<li>Proficiency in medical terminology and clinical documentation practices</li>
<li>Strong interpersonal, verbal, and written communication skills</li>
<li>Organized, detail-oriented, and capable of managing multiple priorities</li>
<li>Proficient in Microsoft Office and other clinical research systems</li></ul><br>
<p></p>
<p>
<b>Apply now</b> to become a part of a team that&rsquo;s changing the future of healthcare&mdash;one trial at a time.</p></div></div><p></p>

Join a workplace recognized by Newsweek as America's Greatest Workplaces for 2024. Advanced Dermatology and Cosmetic Surgery’s mission is to deliver the highest quality patient care and experience in dermatology and aesthetic services. We are currently seeking candidates with exceptional customer service and clinical skills to join our team as a Clinical Research Coordinator.
<br><br>
SUMMARY
<br>The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the supervision of the clinical Principal Investigator (PI). The CRC reports directly to the Director of Clinical Research. While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
<br><br>
<b>ESSENTIAL DUTIES AND RESPONSIBILITIES:</b><br>
<ul>
<li>Coordinates with Principal Investigator, department, and administration to help ensure that clinical research and related activities are performed in accordance with Federal Regulations and sponsoring agency (pharmaceutical and or CRO) policies and procedures.</li>
<li>Assists the PI in study feasibility assessments as requested.</li>
<li>Reviews and comprehends the protocol.</li>
<li>Attends investigator meetings as required or requested by the PI.</li>
<li>Collaborates with the PI to prepare Institutional Review Board (IRB) and any other regulatory submission documents as required by the protocol.</li>
<li>Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs and temperature logs.</li>
<li>Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.</li>
<li>Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.</li>
<li>Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.</li>
<li>Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).</li>
<li>Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.</li>
<li>Conducts or participates in the informed consent process including interactions with the (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.</li>
<li>Develop advertising and other informational materials to be used in subject recruitment.</li>
<li>Identifies and calls possible subjects for recruitment, schedules appointments for study visits, maintains enrollment logs and sends them to study sponsor or CRO.</li>
<li>Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.</li>
<li>Coordinates participant tests and procedures, draws blood or collects urine sample for laboratory testing as specified by the protocol. Prepares the specimens for shipping to laboratory.</li>
<li>Collects data and preforms assessments specified in the protocol; vitals, questionnaires, EKG, photos. Assures timely completion of Case Report Forms.</li>
<li>Maintains study timelines.</li>
<li>Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol on Investigational Drug/Device Accountability. Dispenses study drug to study patients.</li>
<li>Completes study documentation and maintains study files in accordance with sponsor requirements including, but not limited to, consent forms, source documentation, and note to file, case report forms, and investigational material accountability forms.</li>
<li>Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.</li>
<li>Retains all study records in accordance with sponsor requirements in Regulatory binder</li>
<li>Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.</li>
<li>Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, and the sponsoring agency in accordance with Federal regulations and policies and procedures.</li>
<li>Arranges secure storage of study documents that will be maintained according to the contracted length of time, whichever is longer.</li>
</ul>
KNOWLEDGE, SKILLS, AND ABILITIES
<br><ul>
<li>Knowledge of ADCS policies, including quality assurance policies and applicable government regulations and standards, and the ability to actively apply that knowledge in the performance of all job duties</li>
<li>Knowledge of electronic health record access-level privileges and responsibilities, and the ability to perform electronic health record job duties for this position within the parameters of the access level assigned</li>
<li>Ability to practice confidentiality and follow HIPAA regulations with patient information</li>
<li>Ability to practice professional ethics and use discretion concerning ADCS directives and proprietary information/trade secrets of the organization</li>
<li>Ability to recognize a problem and effectively problem-solve, using guidance from the provider and/or management when necessary</li>
<li>Knowledge of medical terminology and ability to use appropriately</li>
<li>Ability to manage time efficiently, prioritize, multi-task, and adapt to change</li>
<li>Ability to maintain high level of accuracy in all documentation and in the performance of all job duties</li>
<li>Ability to perform the essential job duties within the scope of education and training</li>
<li>Skilled in typing/keyboarding; skilled in using computers</li>
</ul>
PROFESSIONALISM
<br><ul>
<li>Project a professional manner and image, including proper workplace attire and grooming standards; exhibit professional conduct at all times.</li>
<li>Adhere to ethical principles and core ADCS values; follow all ADCS policies</li>
<li>Treat all patients and staff with respect, compassion, and empathy, recognizing and respecting cultural diversity</li>
<li>Demonstrate initiative and responsibility for actions</li>
<li>Work as an effective team member</li>
<li>Maintain a strong record for attendance and punctuality in arriving at work</li>
<li>Enhance skills through continuing education</li>
</ul>
EDUCATION
<br>Bachelor's degree in a related field preferred but not required
<br>LICENSURE/CERTIFICATION REQUIREMENTS
<br><ul>
<li>Clinical Research Coordinator (CRC) or Clinical Research Professional (CRP) Certification from SoCRA or ACRP</li>
<li>Good Clinical Practice (GCP) preferred</li>
<li>International Air Transport Association (IATA) Training preferred</li>
</ul>
LANGUAGE/COMMUNICATION REQUIREMENTS
<br><ul>
<li>Ability to read and interpret work-related documents such as reports, communications, safety rules, operating and maintenance instructions, and procedure manuals</li>
<li>Ability to write routine reports and correspondence</li>
<li>Ability to listen, speak, and interact effectively with all patients and co-workers, adapting communication for optimal understanding</li>
<li>Ability to practice professional telephone etiquette and techniques on all calls</li>
</ul>
MATHEMATICAL SKILLS
<br>The ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
<br>REASONING ABILITY
<br>Ability to understand and follow instructions, both written and verbal. Must possess strong problem identification/resolution skills and be able to manage complications involving several variables.
<br>WORK ENVIRONMENT AND CONDITIONS
<br>Work is performed in offices and occasionally research sites. Involves frequent telephone and in-person contact with staff, vendors, providers, and management. Requires some flexibility in working hours. Requires the ability to work in a demanding environment and to effectively resolve conflicts as they arise. Occasional weekend work required. Occasional travel required.
<br>COMPENSATION/BENEFITS
<br><ul>
<li>401K/PTO/Vacation/Benefit Packages</li>
</ul>
<b>NOTE:</b> This job description may not include all duties assigned to the employee and may be updated and modified by Management, without notice, according to operations at any given time.

Clinical Research Coordinator - Winter Park, FL

Kaiser Permanente

<div><div><b>Job Summary:</b></div>
<br>
Collects data for clinical trials research, independently. Prepares and/or supports the submission of study documentation to regulatory bodies (e.g., IRB) for pre-implementation review and approval. May support clinical trials activities and research lab operations. Completes timely and accurate documentation of all research activities (e.g., consent forms, reports). Assists with the development and/or implementation of standard and non-standard quality control and/or assurance measures and documents feedback to research staff and management. Supports and develops materials for the education of research staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions, with limited guidance. Learns about providing input on implementing budgeting components for internally funded standard and non-standard projects. Drafts and/or prepares and submits clinical trials applications in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures.<div><br>
<b>
Essential Responsibilities:</b></div><br>
<br>
<ul><li>Pursues effective relationships with others by proactively providing resources, information, advice, and expertise with coworkers and members. Listens to, seeks, and addresses performance feedback; provides mentoring to team members. Pursues self-development; creates plans and takes action to capitalize on strengths and develop weaknesses; influences others through technical explanations and examples. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work; helps others adapt to new tasks and processes. Supports and responds to the needs of others to support a business outcome.</li><br>
<li>
Completes work assignments autonomously by applying up-to-date expertise in subject area to generate creative solutions; ensures all procedures and policies are followed; leverages an understanding of data and resources to support projects or initiatives. Collaborates cross-functionally to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports, identifies, and monitors priorities, deadlines, and expectations. Identifies, speaks up, and implements ways to address improvement opportunities for team.</li><br>
<li>
Works on budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard and nonstandard projects.</li><br>
<li>
Conducts clinical research by: independently collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments); leveraging a comprehensive foundational knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; leveraging a comprehensive foundational knowledge of clinical trials, studies, and interventions at the site-level; independently contributing to the development of standard and nonstandard clinical research protocols and other processes of clinical trials; preparing and/or supporting the submission of study documentation to regulatory bodies (e.g., IRB) for review and approval prior to implementation; may also be responsible for executing standard and non-standard clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in supporting standard and non-standard research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens).</li><br>
<li>
Ensures research compliance by: independently drafting and/or preparing and submitting clinical trial applications in compliance and consistency with all applicable federal, state, and local regulations, and reviewing and providing input on KP compliance policies and procedures; identifying compliance and/or quality issues and assisting in the development of corrective action plans, escalating as necessary; identifying opportunities to update compliance-monitoring/audit systems and documentation; utilizing standard approaches to analyze risk-management data and making recommendations to mitigate potential risk; independently implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data; and leveraging comprehensive research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines.</li><br>
<li>
Maintains internal and external effective working relationships by: leveraging a comprehensive foundational knowledge of how to partner with research stakeholders and investigators within and across units to contribute to research projects; independently communicating with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions with limited guidance.</li><br>
<li>
Ensures documentation of clinical research files by: completing documentation of all research activities (e.g., consent forms, reports, tracking forms) in a timely and accurate manner; assisting with the development and/or implementation of standard and nonstandard quality control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard procedures and criteria; and leveraging a comprehensive foundational knowledge of how to monitor and audit Clinical Trials as well as documenting findings.</li></ul><div><b><br>
Knowledge, Skills and Abilities: (Core)</b></div><ul><li>
Ambiguity/Uncertainty Management</li><li>
Attention to Detail</li><li>
Business Knowledge</li><li>
Communication</li><li>
Critical Thinking</li><li>
Cross-Group Collaboration</li><li>
Decision Making</li><li>
Dependability</li><li>
Diversity, Equity, and Inclusion Support</li><li>
Drives Results</li><li>
Facilitation Skills</li><li>
Health Care Industry</li><li>
Influencing Others</li><li>
Integrity</li><li>
Learning Agility</li><li>
Organizational Savvy</li><li>
Problem Solving</li><li>
Short- and Long-term Learning &amp; Recall</li><li>
Teamwork</li><li>
Topic-Specific Communication</li></ul><div><b><br>
Knowledge, Skills and Abilities: (Functional)</b></div><ul><li>
Accountability</li><li>
Adaptability</li><li>
Autonomy</li><li>
Business Relationship Management</li><li>
Clinical Research</li><li>
Clinical Research Quality</li><li>
Compliance</li><li>
Computer Literacy</li><li>
Data Quality</li><li>
Experimental Design</li><li>
Innovative Mindset</li><li>
Laboratory Equipment</li><li>
Laboratory Procedures</li><li>
Managing Diverse Relationships</li><li>
Organizational Skills</li><li>
Project Management</li><li>
Project Management Tools</li><li>
Quality Assurance Process</li><li>
Quantitative Research Methods</li><li>
Research Ethics</li><li>
Stakeholder Management</li><li>
Survey Methodology</li><li>
The Scientific Method</li></ul><div><br>
<b>Minimum Qualifications:</b></div><br>
<br>
<ul><li>Bachelors degree in Science, Public Health, Health Care Administration, or related field AND minimum two (2) years of experience in clinical research or a directly related field OR Minimum five (5) years of experience in clinical research or a directly related field.</li></ul><div><b><br>
Preferred Qualifications:</b></div><ul><li>
Certified Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA); OR ACRP Certified Professional, Certified Clinical Research Associate, Certified Clinical Research Coordinator, Certified Principal Investigator, ACRP Medical Device Professional, or ACRP Project Manager from Association of Clinical Research Professionals (ACRP); OR Certified in Healthcare Compliance (CHC) from Healthcare Compliance Association (HCCA).</li><li>
Basic Life Support (BLS) Certification.</li></ul><br>
PrimaryLocation : Oregon,Portland,Center for Health Research<br>
HoursPerWeek : 40<br>
Shift : Day<br>
Workdays : Mon, Tue, Wed, Thu<br>
WorkingHoursStart : 07:00 AM<br>
WorkingHoursEnd : 05:30 PM<br>
Job Schedule : Full-time<br>
Job Type : Standard<br>
Employee Status : Regular<br>
Employee Group/Union Affiliation : NUE-NW-01|NUE|Non Union Employee<br>
Job Level : Individual Contributor<br>
Job Category : Research<br>
Department : Center for Health Research - RI Leadership - 1001<br>
Travel : No<br>
Kaiser Permanente is an equal opportunity employer committed to fair, respectful, and inclusive workplaces. Applicants will be considered for employment without regard to race, religion, sex, age, national origin, disability, veteran status, or any other protected characteristic or status.</div>

Clinical Research Coordinator III, Clinical Trials

Fred Hutchinson Cancer Center

<div>Overview:
<div>
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.</div><div></div><div><br>
With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world&rsquo;s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world&rsquo;s deadliest diseases and make life beyond cancer a reality.</div><div></div><div><br>
At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.</div><div></div><div><br>
The<b> Clinical Research Coordinator II</b> (CRC II) is responsible for day-to-day management of oncology clinical trials. The position will oversee all subject-level study workflows including screening patients for eligibility, coordinating and tracking patient visits and procedures, and creating and maintaining research documentation. The position interfaces with the clinic, providers, investigators, and teams across the clinical research enterprise.</div>
Responsibilities:
<ul><li>Conduct daily clinical operations of assigned research studies in accordance with study protocols, GCP guidelines, applicable regulatory requirements and institutional policies.</li><li>
Coordinate patient enrollment and participation by reviewing study candidates&rsquo; medical records for eligibility, initiating enrollment, ensuring informed consent, and maintaining accurate enrollment records.
</li><li>Schedule patient clinic visits and on-going study visits; ensure compliance with study protocols with respect to clinical procedures, laboratory tests and other patient activities; may administer study questionnaires and ensure drug self-administration accountability with patients.</li><li>
Complete clinical requisition forms as instructed, assemble kits for patient visits, transport laboratory samples and ensure samples are processed and shipped according to study guidelines; track and maintain research supplies.</li><li>
Identify, track and confirm billable activities for patients; work with internal finance team to assist in reviewing clinic charges to ensure billing compliance.</li><li>
Act as protocol liaison with clinical teams, patients, and providers on study related topics.</li><li>
Prepare and coordinate monitoring visits and respond to queries and other requests from study monitors, following up with and resolving any issues that may arise.</li><li>
Assist with maintaining appropriate source documentation and/or performing case report form (CRF) data entry.</li><li>
May travel from South Lake Union campus on shuttle to UW Medical Center (UWMC) Montlake to coordinate patient visits.</li><li>
Other duties as assigned</li></ul>
Qualifications:
<div><b>
MINIMUM QUALIFICATIONS:</b></div><br>
<ul><li>
High school diploma or equivalent.</li><li>
Minimum two to three years&rsquo; experience in a clinical research or cancer registry environment with regulatory or human research protections.</li><li>
Knowledge of clinical trials records, procedures, and computerized data processing systems.</li><li>
Demonstrated knowledge of how to synthesize study conduct.</li></ul><div><b>
PREFERRED QUALIFICATIONS:</b></div><ul><li>
Associate or bachelor&rsquo;s degree preferred.</li><li>
Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).</li><li>
Five years of experience working in clinical research, preferably oncology interventional trials.</li><li>
Working understanding of applicable regulations and guidelines including FDA, ICH GCP, and HHS</li><li>
Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.Strong written and verbal communication skills, including computer skills.</li><li>
Ability to work with multiple data management systems including generating reports and sourcing data from systems.</li><li>
Ability to extract data from medical records and apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.</li></ul><p></p><div>
The hourly pay range for this position is from $31.83 to $47.73 and pay offered will be based on experience and qualifications.<br>
<br>
Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.<br>
<br>
Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).</div>
Additional Information: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.</div>

Clinical Research Coordinator II

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