clinical research professional

Northside Hospital

<div><div><div>Northside Hospital is award-winning, state-of-the-art, and continually growing. Constantly expanding the quality and reach of our care to our patients and communities creates even more opportunity for the best healthcare professionals in Atlanta and beyond. Discover all the possibilities of a career at Northside today.</div></div><div><div>
The Research Nurse I will be responsible for rendering patient care services to patients on research protocols approved through the Northside Hospital IRB. Responsibilities involve patient registration, data collection, data submission, adverse event reporting, patient follow-up, records management, protocol regulatory management, quality assurance and other activities related to research. Major roles of the Research Nurse include those of practitioner, researcher, educator and consultant. The Research Nurse is a professional person with knowledge, skills and abilities in the following areas: specific disease management nursing, data management, physical assessment skills, leadership ability and communication skills.</div></div><div><p><b>
REQUIRED</b></p><ul><li>
Graduate of an accredited school of nursing with a Bachelor or Associate degree and current and unencumbered licensure as a Registered Nurse in the State of Georgia
</li><li>One (1) year relevant work experience in a clinical setting
</li><li>Current and valid American Heart Association Basic Life Support (BLS) Provider CPR &amp; AED Program card</li><li>
If not Certified Clinical Research Coordinator (CCRC) or a Certified Clinical Research Professional (CCRP) at time of hire, must achieve professional certification through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) within three (3) years of hire.</li><li>
If not certified at time of hire, must obtain within three (3) years of hire, one (1) of the following:<ul><li>
FOR ONCOLOGY: Oncology Certified Nurse (OCN) through the Oncology Nursing Certification Corporation (ONCC)</li><li>
FOR BMT: Blood &amp; Marrow Transplant Certified Nurse (BMTCN) through Oncology Nursing Certification Corporation (ONCC)</li></ul></li></ul><p><b>
PREFERRED</b></p><ul><li>
Master of Science degree from an accredited college or university in a data driven research-related field (such as nursing, allied health, biological sciences, chemistry, economics, informatics, mathematics, psychology, sociology, epidemiology, public health).</li><li>
Oncology Certified Nurse (OCN) through the Oncology Nursing Certification Corporation (ONCC).</li><li>
Knowledge and understanding of clinical research healthcare science and Good Clinical Practice (GCP) international quality standards for clinical research.
</li><li>Knowledge of clinical research practices including federal regulations, federal grant and clinical trials policy and regulations, management systems and technology solutions used to coordinate clinical research.</li><li>
One (1) to three (3) years relevant work experience in a clinical or healthcare setting
</li><li>Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA).</li></ul></div></div>

BMT Clinical Research Nurse

Houston Methodist

<div>At Houston Methodist, the Research Coordinator II position is responsible for coordinating the day-to-day activities of research protocols as well as assessing and determining qualification of patients for research studies. Under minimal supervision, this position is responsible for ensuring accurate data collection, documentation, organization and safety of research participants, gathering patient data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.
<div><b>FLSA STATUS</b><br>
Exempt<br>
<br>
<b>QUALIFICATIONS</b><br>
<br>
<b>EDUCATION</b><ul><li>
Bachelor&rsquo;s degree
</li></ul><br>
<b>EXPERIENCE</b><ul><li>
Four years of research experience
</li></ul><br>
<b>LICENSES AND CERTIFICATIONS</b><br>
<b>Required</b><ul><li>
</li></ul><b>Preferred</b><ul><li>
CCRC - Certified Clinical Research Coordinator (ACRP) <b>or</b></li><li>
CCRP - Certified Clinical Research Professional (SOCRA)
</li></ul><br>
<b>SKILLS AND ABILITIES</b><ul><li>
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
</li><li>Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
</li><li>Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
</li><li>Ability to work independently
</li><li>Capable of handling challenging/difficult situations
</li>Demonstrates sound judgment and executes above average analytical skills<br>
<li>
</li></ul><br>
<br>
<b>ESSENTIAL FUNCTIONS</b><br>
<br>
<b>PEOPLE ESSENTIAL FUNCTIONS</b><ul><li>
Under the direction of the Principal Investigator (PI), drafts various communications with the Sponsor and/or regulatory documents to be sent to the Sponsor.
</li><li>Identifies and recruits clinical research subjects and monitors enrollment goals.
</li><li>May conduct in-services to floor nurses/physicians; assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies.
</li><li>Teaches peers to critically think by verbally expressing rationale for decisions and follows up consistently. Uses peer-to-peer accountability towards improvement of department score for turnover/retention/employee engagement.
</li></ul><br>
<b>SERVICE ESSENTIAL FUNCTIONS</b><ul><li>
Participates in the Principal Investigator (PI) meetings.
</li><li>Schedules, coordinates, and participates in the pre-site visit and site initiation visits; coordinates study initiation. Obtains Informed Consent from study participant and documents appropriately.
</li><li>Obtains vital signs and performs phlebotomy per training and competence; monitors participants&rsquo; labs and notifies the PI of laboratory findings.
</li></ul><br>
<b>QUALITY/SAFETY ESSENTIAL FUNCTIONS</b><ul><li>
Prepares Institutional Research Board (IRB) documents under the direction of the PI, assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.
</li><li>Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process. Adheres to internal controls established for the department.
</li></ul><br>
<b>FINANCE ESSENTIAL FUNCTIONS</b><ul><li>
Assists with the budget development and Medicare coverage analysis.
</li><li>Utilizes resources effectively and efficiently, demonstrating responsible financial stewardship. Manages own time effectively and prioritizes work to achieve maximum results in a timely manner.
</li></ul><br>
<b>GROWTH/INNOVATION ESSENTIAL FUNCTIONS</b><ul><li>
Assists PI and/or research nurse in the planning and design of source documents for protocol.
</li><li>Assists in developing procedures for laboratory collection and storage.
</li><li>Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital.
</li>Proactively manages own professional development and completes My Development Plan.<br>
<li>
</li></ul><br>
<br>
<b>SUPPLEMENTAL REQUIREMENTS</b><br>
<ul><b>
WORK ATTIRE</b><li><ul><li>
Uniform: No
</li><li>Scrubs: Yes
</li><li>Business professional: No
</li><li>Other (department approved): Yes
</li></ul></li><br>
<b>ON-CALL*</b><br>
<li><ul><li><i>Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.</i></li></ul></li><li><ul><li>
On Call* No
</li></ul></li><br>
<b>TRAVEL**</b><br>
<i>**Travel specifications may vary by department**</i><li><ul><li>
May require travel within the Houston Metropolitan area No
</li><li>May require travel outside Houston Metropolitan area No
</li></ul></li></ul></div><b>QUALIFICATIONS</b><br>
<br>
<b>EDUCATION</b><ul><li>
Bachelor&rsquo;s degree
</li></ul><br>
<b>EXPERIENCE</b><ul><li>
Four years of research experience
</li></ul><br>
<b>LICENSES AND CERTIFICATIONS</b><br>
<b>Required</b><ul><li>
</li></ul><b>Preferred</b><ul><li>
CCRC - Certified Clinical Research Coordinator (ACRP) <b>or</b></li>
CCRP - Certified Clinical Research Professional (SOCRA)<br>
<li>
</li></ul><br>
<p><b>Company Profile:</b></p><p>
Houston Methodist Academic Institute oversees the Education Institute and Research Institute. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&amp;M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports clinical research protocols and extramurally funded translational research programs.</p><p>
Houston Methodist is an Equal Opportunity Employer.</p></div>

Research Coordinator II - Medicine - Pulmonary COPD

DPMG Clinical research

<p><b>Job Summary</b><br/>We are seeking a dedicated and energetic Registered Nurse to serve as a Clinical Research Coordinator, playing a vital role in advancing medical knowledge through clinical trials. In this dynamic position, you will oversee the coordination and management of clinical research studies, ensuring compliance with regulatory standards, safeguarding patient safety, and maintaining meticulous documentation. Your expertise will help facilitate groundbreaking research that improves patient outcomes and contributes to the development of innovative therapies. This paid position offers an exciting opportunity to combine nursing skills with research excellence in a collaborative environment.</p><p><b>Duties</b></p><ul><li>Coordinate and manage all aspects of clinical trials, including participant recruitment, enrollment, and retention</li><li>Monitor patient health and safety throughout the study, conducting vital signs assessments and blood sampling as needed</li><li>Review and verify study documentation for accuracy, completeness, and compliance with FDA regulations and ICH GCP standards</li><li>Collect, manage, and analyze research data using statistical software and adhere to CDISC standards for data formatting</li><li>Ensure adherence to HIPAA regulations by maintaining patient confidentiality and secure handling of sensitive information</li><li>Conduct clinical laboratory procedures such as blood sampling and phlebotomy with precision and care</li><li>Oversee EMR (Electronic Medical Record) systems to document patient interactions, study progress, and adverse events accurately</li><li>Supervise junior staff or research assistants involved in data collection or patient monitoring activities</li><li>Maintain compliance with all regulatory requirements related to clinical development and research protocols</li></ul><p><b>Requirements</b></p><ul><li>Bachelor&rsquo;s degree in Nursing (RN) <b>required</b>.</li><li>1&ndash;3 years of clinical research experience preferred.</li><li>Fluency in Spanish <b>required</b>.</li><li>Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) is an asset.</li><li>Phlebotomy certification with demonstrated ability to collect, process, and ship specimens in accordance with IATA guidelines.</li><li>Strong knowledge of GCP, FDA, and IRB regulations.</li><li>Excellent organizational, communication, and problem-solving skills.</li></ul><p>Join our team to make a meaningful impact on healthcare innovation! We are committed to supporting your professional growth while fostering a vibrant work environment. This role offers the chance to blend nursing expertise with cutting-edge research initiatives&mdash;empowering you to contribute directly to advancements in medicine.</p><p>Pay: $40.00 - $45.00 per hour</p><p>Expected hours: 40.0 per week</p><p>Benefits:</p><ul><li>Dental insurance</li><li>Flexible schedule</li><li>Health insurance</li></ul><p>Work Location: In person</p>

Registered Nurse - Clinical Research Coordinator

University of Alabama, Birmingham

<div></div><div><div><div><div><div><b>Description</b><div></div><p>
The University of Alabama at Birmingham (UAB), Clinical Research Support Enterprise, is seeking a Manager-Clinical Research Nursing.</p><p><b>
General Responsibilities</b></p><ul><li><p>
To oversee staff in conducting all study activities including more complex protocols in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP).</p></li><li><p>
To assist with the management of the life cycle of the clinical trial as needed from study start-up through trial maintenance to study closure.</p></li><li><p>
To oversee and/or manage multiple clinical research protocols and the associated personnel.</p></li><li><p>
To serve as a resource person or act as a subject matter expert (SME) within area of clinical expertise.</p></li></ul><p><b>
Key Duties &amp; Responsibilities</b></p><ul><li><p>
Provides strategic and operational leadership for the CReSt study startup and clinical research systems infrastructure.</p></li><li><p>
Guides and directs startup workflows to ensure the timely, accurate, and efficient execution of feasibility coordination, protocol calendar development, billing plan alignment, OnCore configuration, and EPIC research integration.</p></li><li><p>
Establishes and monitors startup performance indicators, identifies process inefficiencies, and implements structured workflow improvements to enhance activation timelines and operational performance.</p></li><li><p>
Serves as a clinical and operational subject matter expert (SME) across drug, device, behavioral, and investigator-initiated trials.</p></li><li><p>
Leads process improvement initiatives to strengthen research infrastructure, promote financial stewardship, and ensure compliance with IRB, FDA, and Good Clinical Practice (GCP) standards.</p></li><li><p>
Performs other duties as assigned.</p></li></ul><p><b>
Annual Salary Range</b>: $85,600 - $139,100</p><div><br>
</div></div><div><b>
Qualifications</b><div></div><p>
Bachelor's degree in a related field and eight (8) years of related experience required. <b>Work experience may NOT substitute for education requirement.</b> Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred. Currently licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.</p><p><br>
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.</p><div><br>
</div></div><div><b>
Primary Location</b><b>:</b> University</div><div><b>
Job Category</b><b>:</b> Clinical Research</div><div><b>
Organization</b><b>:</b> 310009510 Clinical Research Support Enterprise</div><div><b>
Employee Status</b><b>:</b> Regular</div><div><b>
Shift</b><b>:</b> Day/1st Shift</div><div><b>
Work Arrangement (final schedule to be determined by the department/hiring manager)</b><b>:</b> Hybrid Eligible</div></div></div></div></div><div></div>

MANAGER-CLINICAL RESEARCH NURSING

University of Virginia

<p></p><div><p>Looking to make a meaningful impact every day? The Office of Clinical Research (OCR) at the University of Virginia Comprehensive Cancer Center is looking for Clinical Research Coordinators, Non-Licensed (multiple levels) to support the advancement of innovative cancer research.</p><p>
In this role, you will help bring new therapies from research to reality by coordinating oncology clinical trials and working closely with patients, physicians, and multidisciplinary research teams. You&rsquo;ll play a key part in ensuring studies are conducted efficiently, ethically, and in full compliance with regulatory and institutional standards.</p><p>
This is an excellent opportunity for detail-oriented, collaborative professionals who are passionate about high-quality research and motivated to contribute to work that improves and extends patients&rsquo; lives.</p><p><b>
What You&rsquo;ll Do</b></p><ul><li><p>
Recruit, screen, consent, and enroll participants across multiple cancer clinical trials</p></li><li><p>
Build trusted relationships with study participants through phone and in-person interactions</p></li><li><p>
Coordinate study visits and collect high-quality data at each visit</p></li><li><p>
Maintain accurate documentation, logs, and study materials</p></li><li><p>
Process, prepare, and ship laboratory specimens</p></li><li><p>
Track adverse events and ensure protocol compliance</p></li><li><p>
Collaborate closely with investigators and the research team to keep studies on track</p></li></ul><p><b>
What You&rsquo;ll Bring</b></p><ul><li><p>
Strong organizational skills and attention to detail</p></li><li><p>
A problem-solver mindset and comfort juggling multiple priorities</p></li><li><p>
Clear, compassionate communication (written and verbal)</p></li><li><p>
The ability to learn quickly and adapt in a fast-paced research environment</p></li><li><p>
A collaborative, team-first approach to your work</p></li></ul><p><b>
Why You&rsquo;ll Love This Role</b></p><ul><li><p>
Make a real impact in cancer research and patient care</p></li><li><p>
Join a mission-driven team at a top academic medical center</p></li><li><p>
Grow your clinical research career with support and mentorship</p></li><li><p>
Work in a role that blends science, organization, and meaningful human connection</p></li></ul><p></p><p><b>
Minimum Requirements for Roles under this Posting:</b></p><p><b>
Clinical Research Coordinator 1, Non-Licensed ($27.80-29.30)</b><br>
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.<br>
Experience: None. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.</p><p></p><p><b>
Clinical Research Coordinator- 2, Non-Licensed ($63,000 - $66,000)</b><br>
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.<br>
Experience: At least one year of clinical research experience. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.</p><p></p><p><b>
Clinical Research Coordinator- 3, Non-Licensed ($71,500 - $74,500)</b></p><p>
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.<br>
Experience: Minimum of 3 years of clinical research experience required. Master&rsquo;s degree may substitute for 1 year of clinical research experience.<br>
**Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.**</p><p></p><p><b>
Clinical Research Coordinator- 4, Non-Licensed ($78,500 - $81,500)</b></p><p>
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.<br>
Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master&rsquo;s or other advanced degree may substitute for one year of clinical research experience.<br>
**Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required.**</p><p></p><p><b>
Physical Demands</b>: This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.</p><p><b>
Funding Details:</b> This is a restricted position, which is dependent on funding and is contingent upon funding availability.</p><p><b>
Work Arrangement: </b>This position is based in Charlottesville, VA, and must be performed fully on-site.</p><p><b>
About UVA and the Community: </b>To learn more about UVA and in the Charlottesville area, visit UVA Life and Embark CVA.</p><p></p><p>
This evergreen job posting is used to build a talent pool for the<b> Clinical Research Coordinator Varying Levels (Non-Licensed)</b> job family. Positions may open periodically within the [Cancer Center], and applications to this pool will be reviewed on a recurring basis.</p><p><b>
Key Information</b></p><ul><li><p>
This is not a posting for a single, immediate vacancy.</p></li><li><p>
Applicants may be considered for any CRC role for which they meet the minimum qualifications.</p></li><li><p>
Applications remain active for a limited time and are reviewed and dispositioned quarterly.</p></li><li><p>
If you need to update your application, please visit your Applicant Profile and edit any relevant saved information, or contact the supporting recruiter listed for this requisition.</p></li><li><p>
Candidates who are still interested after a review cycle closes are encouraged to reapply to future evergreen postings.</p></li></ul><p>
Submitting an application indicates your interest in future Clinical Research Coordinator opportunities within the UVA School of Medicine Cancer Center.</p><p></p><p><b>
Background Check: </b>Background checks, pre-employment health screenings, and drug screenings will be conducted on all new hires prior to employment.</p><p><b>
Visa Sponsorship:</b> This position <b>will not </b>consider candidates who require immigration sponsorship now or in the future.</p><p><b>
How to Apply: </b>Please apply <b>online</b>, by searching for requisition number <b>R0081545</b>. Complete an application with the following documents:
</p><ul><li><p><b>Resume
</b></p></li><li><p><b>Cover Letter</b></p></li></ul><p>
Upload all materials into the resume submission field. You can submit multiple documents into this one field or combine them into one PDF. Applications without all required documents will not receive full consideration.</p><p></p><p><b>
Internal applicants: </b>Search and apply for jobs on the UVA Internal Careers website.</p><p><b>
Reference Check Process: </b>Reference checks will be completed by UVA&rsquo;s third-party partner, SkillSurvey, during the final phase of the interview. Five references will be requested, with at least three responses required.</p><p><b>
Recruiter Contact: </b>For questions about the application process, please contact Jeremy Brofft.
</p><p></p><p>MINIMUM REQUIREMENTS</p><p>
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.</p><p>
Experience: None. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.</p><p>
Licensure: None.</p><p></p><p>
PHYSICAL DEMANDS</p><p></p><p>
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.</p><p></p><p><i>
The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Learn more about </i><i>UVA&rsquo;s commitment to non-discrimination and equal opportunity employment</i><i>.</i></p></div>

Clinical Research Coordinator-Varying Levels(Non-Licensed)-Cancer Center

Johns Hopkins Health System

<div></div><div><div><div>Requisition #:</div><div>
664849</div>
<div>Location:</div><div>
Johns Hopkins All Children's Hospital, St. Petersburg, FL 33701
</div><div>Category:</div><div>
Allied Health/Clinical Professional</div>
<div>Schedule:</div><div>
Day Shift</div>
<div>Employment Type:</div><div>
Full Time</div>
</div>
<p></p><div><div><p><b>POSITION SUMMARY:</b></p>
<p>
An advanced member of the study team who under the direction of the Principal Investigator and Director of Research Operations is responsible for the overall coordination of assigned studies including screening, recruitment, data collection, and data entry to ensure protocol compliance and human subjects&rsquo; protection.</p>
<p><b>
Shift</b>: Full Time/Day Shift</p>
<p><b>
Location</b>: St Petersburg, FL</p>
<p><b>
KEY ACCOUNTABILITIES:</b></p>
<div>
<ul><li>Serve as the primary coordinator on more-than-minimal-risk, high acuity, and/or complex studies. Serves as the liaison between study team, research cores/units/departments, ancillary hospital departments/services, sponsor, and IRB to ensure cross-communication and protocol compliance</li></ul>
<ul><li>Delegate tasks to the Clinical Research Coordinator I and Research Assistant in accordance with the delegation of authority log to ensure study is executed appropriately and efficiently</li></ul>
<ul><li>Coordinate the preparation and submission of regulatory documentation to the sponsor and Institutional Review Board (IRB) during all phases of study conduct including start-up, continuing reviews, changes in research, problem events, and closure to ensure human subjects protections and regulatory compliance</li></ul>
<ul><li>Operationalize the recruitment plan and obtain or coordinate the informed consent process to ensure the participant understands the information and volunteers to participate free of coercion</li></ul>
<ul><li>Coordinate and/or perform study visits/interventions/observations to ensure they are conducted according to protocol</li></ul>
<ul><li>Monitor participants for adverse events and study conduct for protocol deviations and events and report accordingly to Principal Investigator, sponsor, and IRB to ensure participant safety and protocol compliance, and participate in the Corrective and Preventative Action planning where applicable</li></ul>
<ul><li>Coordinate and perform data collection from various sources including medical records and enter data into research database to ensure accurate and timely data entry</li></ul>
<ul><li>Maintain organized and up-to-date research records including regulatory binders and participant records to ensure study documentation is audit-ready</li></ul>
</div>
<p><b>QUALIFICATIONS:
</b></p><ul><li>Bachelor&rsquo;s degree in science or health related field
</li><li>3 years of prior clinical research coordination or nursing experience required</li>
<li>Certified as a Clinical Research Professional, or will obtain CCRP within 6 months of becoming eligible, but no later than 2 years after hire</li>
<li>Demonstrates knowledge and skills in accordance with Good Clinical Practice (GCP) guidelines, HIPAA, FDA regulations and other federally mandated guidelines</li>
<li>Must be comfortable working with patient populations</li>
<li>Computer competency in using Microsoft Office including Word, Excel, and Outlook; prior experience with Electronic Data Capture (EDC) systems or databases is preferred</li>
<li>Ability to grasp the rationale for the methods used and careful attention to details of the protocols</li>
<li>Proficient knowledge of medical terminology and human subject research</li>
</ul>
<p><b>Salary Range:</b> Minimum 27.85/hour - Maximum 44.57/hour. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility. In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority.</p>
<p>
We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences, where all employees feel valued, contribute to our mission of serving the community, and engage in equitable healthcare delivery and workforce practices.</p>
<p>
Johns Hopkins Health System and its affiliates are drug-free workplace employers.</p>
</div><p></p>
</div><p>Johns Hopkins Health System and its affiliates are an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, mental or physical disability, genetic information, veteran status, or any other status protected by federal, state, or local law.</p></div><div></div>

Clinical Research Coordinator II - Oncology

The University of Michigan

<p></p><div><div><div><h2 class="jobSectionHeader"><b>How to Apply</b></h2><p>
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.</p><h2 class="jobSectionHeader"><b>
Job Summary</b></h2><p>
This position will serve as a Clinical Research Coordinator Senior in the Oncology Clinical Trial Support Unit (O-CTSU) - providing operational and administrative support for the clinical research oversight committees and providing protocol development support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 175 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers?. Help discover them.</p>
<p>This Clinical Research Coordinator (CRC) position will provide study oversight of multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Intermediate position on the Michigan Medicine CRC Career Ladder is required. This position gives back to the institution through mentoring others on study regulations and best practices and participating in training and development of junior clinical research professionals. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and mentor study team members on internal compliance requirements and NCI guidelines. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This level of CRC develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. This position continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, develop, evaluate, guide, mentor, and support.</p><h2 class="jobSectionHeader"><b>
Mission Statement</b></h2><p>
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.</p><h2 class="jobSectionHeader"><b>
Why Join Michigan Medicine?</b></h2><p>
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.</p><p><b>
What Benefits can you Look Forward to?</b></p><ul><li>
Excellent medical, dental and vision coverage effective on your very first day</li><li>
2:1 Match on retirement savings</li></ul><h2 class="jobSectionHeader"><b>
Responsibilities*</b></h2><p><b>
Characteristic Duties and Responsibilities:</b></p><p>
Independent knowledge, skills, and abilities within all 8 competency domains is expected:</p><ul><li>
Scientific Concepts and Research Design</li><li>
Ethical Participant Safety Considerations</li><li>
Investigational Products Development and Regulation</li><li>
Clinical Study Operations (GCPs)</li><li>
Study and Site Management</li><li>
Data Management and Informatics</li><li>
Leadership and Professionalism</li><li>
Communication and Teamwork</li></ul><p>
This position reports directly to a unit Administrator.</p><p>
As a member of a compliance team, this position independently provides operational and administrative support for the clinical research oversight committees. This position may also contribute to the development of protocols with varying levels of complexity to enhance the administration and execution of clinical trials.</p><ul><li>
Oversees regulatory documentation for quality assurance. Reviews new study applications and amendment submissions for completion and accuracy.</li><li>
Ensures protocols contain the minimum standard requirements for committee review, including plans for monitoring site compliance of subject safety reporting.</li><li>
Establishes meeting agendas, records meeting minutes, and provides committee outcome notifications. Develops and maintains accurate tracking systems for committee activities and audit files.</li><li>
Acts as a liaison between the committee, investigators, research teams, etc. to get questions answered and issues resolved.</li><li>
Assists investigators with the development and maintenance of investigator-initiated cancer clinical research protocols. Collaborates with investigators and institutional partners to produce high quality protocol documents meeting federal regulations and institutional standards that also reduce ambiguity and provide clarity of execution by other CRCs. Maintains and updates master protocol templates for studies clinically coordinated under Rogel Cancer Center.</li><li><p>
Provides supportive training, group mentorship, and individual coaching of novice regulatory staff supporting cancer-related studies on internal compliance requirements and NCI guidelines.</p></li></ul><h2 class="jobSectionHeader"><b>
Required Qualifications*</b></h2><p><b>
Clinical Research Coordinator - Senior</b></p><ul><li>
Mastery of all job duties from the Clinical Research Intermediate position is required.</li><li>
Bachelor's degree in health science or an equivalent combination of related education and experience.</li><li>
Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SoCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at the date of hire, and the certification must be completed or passed etc. within six months of date of hire.</li><li>
Minimum 5 years of directly related experience in clinical research compliance oversight and/or clinical research and clinical trials is necessary.</li><li>
Knowledge of research regulations and best practices.</li><li>
Excellent communication, interpersonal, and organizational skills.</li><li>
Ability to work independently, prioritizing multiple tasks to meet deadlines.</li></ul><p><b>
Clinical Research Coordinator - Intermediate</b></p><ul><li>
Mastery of all job duties from the Clinical Research Associate position is required.</li><li>
Bachelor's degree in health science or an equivalent combination of related education and experience.</li><li>
Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SoCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at the date of hire, and the certification must be completed or passed etc. within six months of date of hire.</li><li>
Minimum 3 years directly related experience in clinical research and clinical trials is necessary.</li><li>
Knowledge of research regulations and best practices.</li><li>
Excellent communication, interpersonal, and organizational skills.</li><li><p>
Ability to work independently, prioritizing multiple tasks to meet deadlines.</p></li></ul><h2 class="jobSectionHeader"><b>
Desired Qualifications*</b></h2><p><b>
Clinical Research Coordinator - Senior</b></p><ul><li>
9+ years of direct related experience.</li></ul><p><b>
Clinical Research Coordinator - Intermediate</b></p><ul><li>
6+ years of direct related experience.</li></ul><h2 class="jobSectionHeader"><b>
Work Schedule</b></h2><p>
Monday through Friday, core business hours. Occasionally evening or weekend work to meet deadlines.</p><h2 class="jobSectionHeader"><b>
Modes of Work</b></h2><p>
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.</p><h2 class="jobSectionHeader"><b>
Underfill Statement</b></h2><p>
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.</p><h2 class="jobSectionHeader"><b>
Background Screening</b></h2><p>
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.</p><h2 class="jobSectionHeader"><b>
Application Deadline</b></h2><p>
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.</p><h2 class="jobSectionHeader"><b>
U-M EEO Statement</b></h2><p>
The University of Michigan is an equal employment opportunity employer.</p></div></div></div><p></p>
<br><div><div><h3 class="jobSectionHeader"><b>Job Opening ID</b></h3>
<div><p>275078</p>
</div></div><div><h3 class="jobSectionHeader"><b>Working Title</b></h3>
<div><p>Clinical Research Coord Senior</p>
</div></div><div><h3 class="jobSectionHeader"><b>Job Title</b></h3>
<div><p>Clinical Research Coord Senior</p>
</div></div><div><h3 class="jobSectionHeader"><b>Work Location</b></h3>
<div><p>Ann Arbor Campus</p>
</div></div><p>Ann Arbor, MI</p>
<div><h3 class="jobSectionHeader"><b>Modes of Work</b></h3>
<div><p>Hybrid
</p></div></div><div><h3 class="jobSectionHeader"><b>Full/Part Time</b></h3>
<div><p>Full-Time</p>
</div></div><div><h3 class="jobSectionHeader"><b>Regular/Temporary</b></h3>
<div><p>Regular</p>
</div></div><div><h3 class="jobSectionHeader"><b>FLSA Status</b></h3>
<div><p>Exempt</p>
</div></div><div><h3 class="jobSectionHeader"><b>Organizational Group</b></h3>
<div><p>Medical School</p>
</div></div><div><h3 class="jobSectionHeader"><b>Department</b></h3>
<div><p>MM O-CTSU Administration</p>
</div></div><div><h3 class="jobSectionHeader"><b>Posting Begin/End Date</b></h3>
<div><p>3/17/2026 - 4/07/2026</p>
</div></div><div><h3 class="jobSectionHeader"><b>Career Interest</b></h3>
<div><p>Research</p></div></div></div>

Clinical Research Coord Senior

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