research study coordinator

Headlands Research

<div><div>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.</div> 

<h1 class="jobSectionHeader">
Clinical Research Coordinator (CRC)</h1>

 Location: Pikesville, MD | Site Name: Headlands Research - Pharmasite | Full-Time 


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.

We're seeking a Clinical Research Coordinator (CRC) 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.

Type: Regular Full-time Employee 
Schedule: Mondays through Fridays, 8:00am - 5:00pm 
Location: Onsite in Pikesville, MD (no capabilities for remote or hybrid work) 
Reports to: Site Director 
Benefits: 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.
<h2 class="jobSectionHeader">
 What We Offer</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> 


<h2 class="jobSectionHeader"> Why Join Us?</h2>

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. 


Responsibilities:
<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> 


Requirements:
<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> 


 Apply now to become a part of a team that's changing the future of healthcare&mdash;one trial at a time.</div>

Clinical Research Coordinator

University of Minnesota

<div>All required qualifications must be documented on application materials.
Required Qualifications:<ul><li>
Bachelors&rsquo; degree plus at least 4 years of clinical or research experience or a combination of related education and relevant work experience to equal at least eight years</li><li>
Relevant and direct experience in clinical research to include data management and following clinical research Standard Operating Procedures, the Code of Federal Regulations for clinical trials and Good Clinical Practice guidelines.</li><li>
Demonstrated computer proficiency and ability to navigate multiple software applications.</li><li>
Detail-oriented with exceptional organizational, planning and problem-solving skills.</li><li>
Ability to work in a complex environment.</li><li>
Ability to work independently, as a part of a team and with changing priorities.</li><li>
Possess excellent communication (written and verbal) and interpersonal skills.</li></ul>
Preferred Qualifications:<ul><li>
Certified Clinical Research Coordinator.</li><li>
Certification (COA/COT) or relevant experience as an Ophthalmic Technician.</li><li>
Previous experience with Ophthalmology specialty.</li><li>
Experience in both adult and pediatric studies.</li><li>
Relevant and direct experience with regulatory requirements including study monitoring, Institutional Review Board submissions, Investigation New Drug (IND) and/or Investigational Device (IDE) submissions.</li><li>
Experience with Epic or other electronic medical record system.</li></ul>
The Clinical Research Coordinator provides overall study management for research faculty on a variety of research studies to include; business and industry studies, investigator-initiated studies and NIH sponsored research. This position reports to the Department Administrator.
The research coordinator is a key member of the department&rsquo;s research team and responsibility will manage research projects across the adult ophthalmology program and will provide some back up support of the pediatric program. Troubleshooting and independent problem solving skills will be important in this role. The position collaborates with other areas of the University to include Clinical Translational Science Institute (CTSI) clinical research services, and the staff in the Ophthalmology clinic and MHealth Fairview research clinic in assuring that studies meet regulatory requirements, policies and procedures are completed according to the study protocol. .
Job Responsibilities:
Research Study Coordination (60%)<ul><li>
Work closely with the Investigators in subject screening and recruitment, verifying subject eligibility, facilitating subject enrollments, and timely acquisition of research samples.</li><li>
Provide effective specimen management, including preparing kits, preparing shipments, tracking inventory, etc.</li><li>
Responsible for complete and accurate study data collection, through patient interactions, survey management, electronic medical records, etc.</li><li>
Perform ophthalmic technical procedures (e.g., visual acuity, tonometry, perimetry, imaging) as required by the study protocol, minimizing the need for outside clinical staff support.</li><li>
Create source documents for accurate data collection.</li><li>
Responsible for the maintenance of subject research charts in adherence to Good Clinical Practice and sponsor requirements.</li><li>
Implement a process to track subject visits and ensure protocol timelines are met.</li><li>
Enter all study and subject data into OnCore clinical trials management system and required sponsor platforms.</li><li>
Work with the Investigators to ensure the timely review and reporting of adverse reactions and severe adverse events.</li><li>
Entering all study subjects visits appropriately to make sure patient billing is accurate.</li><li>
Implement and maintain accurate subject Clincard payments.</li><li>
Lead and manage relationships with sponsors and contractors to conduct site initiation visits, monitoring visits, program audits, etc.</li><li>
Responsible for implementing accurate device and drug accountability processes according to sponsor and regulatory requirements.</li></ul>
Research Project Management Duties (30%)<ul><li>
Responsible for research study start up process to include Preparation of regulatory applications, consent and HIPAA forms and applicable documents to meet institution and sponsor requirements.</li><li>
Liaison between department and the University IRB staff and associated Ancillary Reviews to ensure applicable review are completed (Fairview, Hipco, CTSI, Scientific Review).</li><li>
Work with CTSI Regulatory Services to support Business and Industry protocols to include local and central IRB applications.</li><li>
Develop and manage a tracking system to ensure regulatory review submissions, modification and continuing review deadlines are met.</li><li>
Maintenance of regulatory binders (paper and electronic) and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time.</li><li>
Responsible for implementation of the research protocol in collaboration with the clinical teams to foster an environment of quality research participation within the context of exceptional clinical care.</li><li>
Oversee and responsible for the completion of the study budget process including review of protocol amendments to ensure the budget supports the work required.</li><li>
Work with the department accountant(s) to monitor incoming study payments.</li><li>
Maintain the Oncore system to ensure billing compliance and accurate documentation.</li><li>
Track clinical research projects across the department to include medical students, residents and fellows to ensure projects are tracked and in compliance with the IRB.</li></ul>
Coordinate Research Studies for the department (5%)<ul><li>
Coordinate research studies for other departments who require ophthalmology services for eligibility.</li><li>
Work with patients to schedule appointments, be present for the exam, complete all required source documentation for primary Clinical Research Coordinator.</li><li>
Provide support and assistance to the clinical research team.</li></ul>
Misc. educational and department duties (5%)<ul><li>
Attend bi-monthly CTSI Clinical Research Professional Development Seminars and other educational opportunities as appropriate.</li><li>
Support quality improvement initiatives.</li></ul>
The Department of Ophthalmology and Visual Neurosciences and its success is built upon the innovation and drive of every member of our team, from faculty to administrators to technicians. Put simply, all of us are driven to provide the best eye care for our patients, discover new treatments, and educate the next generation of eye care professionals. 
For more information please visit our website at https://med.umn.edu/Ophthalmology.
Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.
Additional documents may be attached after application by accessing your &quot;My Job Applications&quot; page and uploading documents in the &quot;My Cover Letters and Attachments&quot; section.
To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.
The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.
The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu
Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.
The University of Minnesota, Twin Cities (UMTC)
The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.
At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America&rsquo;s Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).</div>

UCLA Health

<div><div>Description
The Department of Medicine, Division of Gastroenterology is seeking to hire an Assistant Clinical Research Coordinator to support the successful execution of clinical research studies and trials. In this role, you will work closely with the Clinical Research Coordinator and Senior Clinical Research Coordinator to keep studies running smoothly, on schedule, and in full compliance with protocols and regulations.
You will assist with day‑to‑day study operations, help organize and prioritize project tasks, and ensure key activities are completed accurately and on time. Your work will directly support study planning, regulatory adherence, and overall trial management&mdash;making you an essential part of the research team.
This position is ideal for someone detail‑oriented, proactive, and eager to grow in clinical research while contributing to studies that advance patient care and medical knowledge.
Hourly range: $29.28-$47.10</div><div>
Qualifications
Required:<ul><li>
Ability to work efficiently and complete tasks with thoroughness and accuracy</li><li>
Strong verbal and written communication skills along with strong interpersonal skills to effectively establish rapport, and build relationships.</li><li>
Strong organizational capabilities.</li><li>
Skills sufficient to solve problems and identify solutions</li><li>
Ability to adapt to changing job demands and priorities; work flexible hours to accommodate research deadlines.</li><li>
Ability to respond to situations in an appropriate and professional manner.</li><li>
Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines.</li><li>
Ability to be flexible in handling work delegated by more than one individual.</li><li>
Typing and computer skill/ability including word-processing, use of spreadsheets, email, data entry.</li><li>
Ability to navigate numerous software programs and applications.</li><li>
Ability to handle confidential material information with judgement and discretion.</li><li>
Skill in coordinating information transfer among multiple constituents.</li></ul>
Preferred:<div><ul><li>
Experience in a Health Care Setting</li></ul></div></div></div>

Assistant Clinical Research Coordinator

Columbia University

<div><ul><li>Job Type: Officer of Administration</li>
<li>Regular/Temporary: Regular</li>
<li>Hours Per Week: 35</li>
<li>Salary Range: $69,500 - $72,500 Annual</li>
</ul><div>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div>

Position Summary

The Clinical Research Coordinator I is an intermediate level position that provides independent study coordination for simple and moderately complex clinical research studies such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies or under supervision provides study coordination for moderate complexity to high complexity clinical trials with supervision such as such as EFS and pivotal IDE/IND studies. Responsible for consent, screening for eligibility and identification of AES under minimal supervision. Completes subject follow ups, source documentation, device accountability and preparing for monitoring visits independently. The CRC I should be capable of independently performing tasks, making decisions, and consistently delivering accurate and high-quality work. They possess a moderate level of expertise across various skills and abilities within their function on the research team.

Responsibilities

CLINICAL COORDINATION
<ul>
<li>May create a recruitment plan that addresses the needs of the study population.</li>
<li>Demonstrates ability to screen participants for study eligibility &amp; enroll with accuracy in various databases.</li>
<li>Demonstrates ability to find and utilize information from EMR and databases/CTMS/EDC.</li>
<li>Demonstrates understanding of protocol elements/requirements and demonstrate the ability to execute study procedures.</li>
<li>Understands protocol structure and how to interpret study requirements to ensure study compliance.</li>
<li>Understands proper documentation techniques as outlined in the ICH-GCP guidelines.</li>
<li>May complete P-card reimbursement to patients.</li>
<li>Processes subject visit billing and tracking of invoiceable items.</li>
<li>Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.</li>
<li>Obtains informed consent from subject.</li>
<li>Conducts all startup, active implementation, and closeout activities</li>
<li>Assesses studies for execution and troubleshoots potential implementation issues.</li>
<li>Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.</li>
<li>Triages subject concerns and issues appropriately.</li>
<li>Performs moderately complex study procedures with accuracy.</li>
</ul>
DATA COORDINATION
<ul>
<li>Enters data to complete forms (CRFs) on paper, databases, or EDCs.</li>
<li>Demonstrates ability to resolve moderately complex queries (e.g., data error changed numerous values in EDC).</li>
<li>Explains how to utilize information from the EMR and study databases.</li>
<li>Demonstrates the ability to complete moderately complex data collection during study visits.</li>
<li>Demonstrates the ability to document data in accordance with ALCOA-C principles.</li>
<li>Administers surveys and questionnaires.</li>
<li>Demonstrates ability to perform concomitant medications abstraction.</li>
<li>Builds patient research study charts.</li>
<li>Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned.</li>
<li>Contributes to the development of processes and tools to capture data in accordance with ALCOA- C principles.</li>
<li>Demonstrates the ability to create CRFs, study documents, and tools.</li>
<li>Knowledge of the elements and development of an effective corrective and preventive action plan (CAPA).</li>
<li>Creates and manage databases.</li>
</ul>
REGULATORY COORDINATION
<ul>
<li>Uses proper documentation techniques as outlined in the ICH-GCP guidelines.</li>
<li>Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines.</li>
<li>Assists Regulatory manager in submission and management of IRB applications.</li>
<li>Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and UP and understands how to report appropriately.</li>
<li>Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.</li>
<li>Demonstrates an understanding of the elements of subject safety, related documentation, and reporting.</li>
<li>Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.</li>
<li>Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes.</li>
</ul>
ADMINISTRATIVE RESPONSIBILITIES
<ul>
<li>Provides other administrative support for study activity including scanning, filing, etc. of research documents; managing organization of research kits.</li>
<li>Communicates with study participants such as sending study correspondence via mail or email.</li>
<li>Schedules subjects for research visits and FU appointments.</li>
<li>Checks study calendar for completion of study procedures.</li>
<li>Manages study supply inventory.</li>
<li>Utilizes documents and systems to track recruitment and retention of participants.</li>
<li>Participates in regular study meetings.</li>
<li>Provides logistic and regulation guidance to entry level employees on Federal and University policy and guidelines.</li>
<li>Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolve.</li>
</ul>
TRAINING
<ul>
<li>Gains appropriate training &amp; knowledge of EMR, CTMS, EDC, databases, etc. as assigned.</li>
<li>Attends and participates in all training assigned to this level including CITI, GCP, HIPAA.</li>
<li>Understands the disease process per program.</li>
<li>Participates in trainings specifically for maintaining certification as a Clinical Research Professional.</li>
<li>Provides training and mentorship for CRC clinical research staff on communication and teamwork best practices.</li>
<li>Attends and participates in all training assigned to this level.</li>
</ul>
COMPETENCY
<ul>
<li>Functional Knowledge: Demonstrates a strong understanding of the research subject matter specific to their role on the team.</li>
<li>Problem Solving: Analyzes moderately complex situations and apply education, experience, judgment, and precedent to identify and implement effective solutions.</li>
<li>Decision Making/Autonomy: Carries out research projects per guidelines and regulation with limited supervision, collaborating both independently and with the Principal Investigator (PI) and Clinical Research Manager. Requires a moderate degree of initiative and independent judgment.</li>
<li>Communication Skills: Summarizes and explains research information to others effectively.</li>
</ul>
Perform other responsibilities as assigned.

Please note that specific responsibilities may vary based on the needs of your unit or team. Certain units may require a greater focus on clinical, data, regulatory, or other specific needs. The role of Clinical Research Coordinator may support task-oriented requirements within the broader context of clinical research coordination.

Minimum Qualifications
<ul>
<li>Bachelor's degree or equivalent in education and/or experience, plus 3 years of experience.</li>
<li>Mastered competency of the specific responsibilities and duties from the CRC.</li>
<li>Technical competency in areas such as regulatory requirements, data management, and study documentation.</li>
<li>Experience in managing study-specific procedures, including patient eligibility screening, informed consent, and adverse event reporting.</li>
</ul>
Other Requirements
<ul>
<li>Participation in the medical surveillance program:
<ul><li>Contact with patients and/or human research subjects.</li>
</ul></li><li>Successful completion of applicable compliance and systems training requirements.</li>
</ul>
Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.</div>

Clinical Research Coordinator I - Cardiology (CARE)

Innovo Research

<div>
 
 Description
 
 
 
 
 JOB SUMMARY
 
 
 
 A Clinical Research Coordinator (CRC) is responsible for reviewing, processing, and managing clinical research data and documents, both regulatory and patient records. The CRC performs a variety of clinical procedures, and assists with daily workload planning; ie; collect, record, report, and interpret data on patients enrolled in and/or seeking enrollment in clinical studies according to the protocol, SOPs, and GCPs.
 
 
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Provide clinical research support to investigators to prepare for and execute assigned research studies, including:
 </li>
 <ul>
 <li>
 Collect, record, and maintain research subject study data according to study protocols and SOPs, preserving quality control for content, accuracy, and completeness.
 </li>
 <li>
 Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research.
 </li>
 <li>
 Recruit and screen participants for clinical trials and maintain subject screening logs.
 </li>
 <li>
 Assist in the initial and ongoing consent process; orient research subjects to the study, including the purpose of the study, procedures, and research process.
 </li>
 <li>
 Maintain source documentation based on protocol requirements.
 </li>
 <li>
 Schedule and execute study visits and perform study procedures.
 </li>
 <li>
 Handle lab testing and analysis, including preparation of specimen collection tubes, shipment, and lab logistics.
 </li>
 <li>
 Monitor subject safety and report adverse events/reactions to the Principal Investigator and/or appropriate medical personnel.
 </li>
 <li>
 Correspond with research subjects and troubleshoot study-related questions or issues.
 </li>
 <li>
 Participate in ?huddles? to confirm daily study tasks are assigned to team members and are executed to the expected standards.
 </li>
 </ul>
 <li>
 Assist with study data quality checking and query resolution.
 </li>
 <li>
 Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring, if needed.
 </li>
 <li>
 Assist the investigator in verifying that research study objectives are met on time, within budget, and according to applicable protocol requirements, clinical research regulations, and quality standards.
 </li>
 <li>
 Provide training to new investigator site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
 </li>
 <li>
 Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.
 </li>
 <li>
 Assist the research site with coverage planning related to staffing and scheduling for research studies.
 </li>
 <li>
 Monitor subject safety and report adverse reactions to appropriate medical personnel.
 </li>
 <li>
 Maintain confidentiality of data and PHI as required.
 </li>
 <li>
 Collaborate with provider offices to carry out research in the most efficient workflow possible.
 </li>
 <li>
 Maintains stock of supplies needed to carry out each study per protocol.
 </li>
 <li>
 Performs other duties and projects as assigned.
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 QUALIFICATIONS
 
 
 
 <ul>
 <li>
 Bachelor's degree in a related field
 </li>
 <li>
 1-2 years of clinical research experience
 </li>
 <li>
 Relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training, and experience
 </li>
 <li>
 Proficient in the use of Microsoft Office applications
 </li>
 <li>
 Understanding of medical terminology
 </li>
 <li>
 Working knowledge of clinical trials
 </li>
 <li>
 Knowledge and ability to apply GCP/ICH and all applicable FDA regulations and guidelines for human subject protection, drug, and device.
 </li>
 <li>
 In-depth knowledge of departmental, protocol, and study-specific operating procedures, consent forms, and study schedules
 </li>
 <li>
 Skilled in carrying out required clinical procedures such as phlebotomy and vital signs.
 </li>
 <li>
 Strong written and verbal communication skills including good command of the English language.
 </li>
 <li>
 Skill in applying and modifying professional research principles, methods, and techniques to provide ongoing patient care.
 </li>
 <li>
 Skill in preparing/maintaining records, writing reports, and responding to correspondence.
 </li>
 <li>
 Ability to maintain quality control standards.
 </li>
 <li>
 Ability to react calmly and effectively in all situations.
 </li>
 <li>
 Excellent organizational and problem-solving skills.
 </li>
 <li>
 Effective time management skills with the ability to multi-task and manage competing priorities with exceptional attention to detail.
 </li>
 <li>
 Ability to establish and maintain effective working relationships with physicians, coworkers, managers, and clients.
 </li>
 <li>
 Practice a high level of integrity, honesty, and in maintaining confidentiality.
 
 
 </li>
 </ul>
 
 BENEFITS (Full-Time)
 
 
 
 <ul>
 <li>
 Competitive salary
 </li>
 <li>
 Health Insurance
 </li>
 <li>
 Dental Insurance
 </li>
 <li>
 Disability Insurance
 </li>
 <li>
 Life Insurance
 </li>
 <li>
 Paid Time Off
 </li>
 <li>
 Vision Insurance
 
 
 </li>
 </ul>
 
 WORKING CONDITIONS
 
 
 
 This job operates in a professional and clinical environment with occasional visits to other Innovo Research partner sites/clinics. This role routinely uses standard office equipment such as computers, phones, and scanners. There is frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations, and other conditions common to a clinic environment. Varied activities include standing, walking, reaching, bending, and lifting. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 50 pounds. Requires corrected vision and hearing to normal range.
 
 
 Due to the nature of this position, employees are expected to work in person. This is an exempt position under the federal and state wage and hour laws, which means you are not eligible for overtime pay beyond your salary. Employees are expected to work 40 hours a week. Occasional evening and weekend work may be required as job duties demand.
 
 
 The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Innovo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. In addition, Innovo will provide reasonable accommodations for qualified individuals with disabilities.
 
 
 Applicants must be authorized to work for ANY employer in the U.S. Innovo Research is unable to sponsor or take over sponsorship of an employment Visa at this time.
</div>

UT Southwestern Medical Center

WHY UT SOUTHWESTERN?
 With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!
 
JOB SUMMARY
 Works under the direction of an Investigator(s) with general supervision, to provide ongoing data management for local and national research studies and may coordinate observational (non-treatment/treatment) trials/studies. May provide supporting role for more complex studies under the direction of the PI, Clinical Research Coordinator and/or Clinical Research Lead.
 
Works under the direction of Investigators and the Research program manager with limited supervision to coordinate clinical research projects. The position primarily coordinates patient participation, research visits, conduct data management and ensures the quality control of clinical research data is support of multiple drug, device or biorepository complex research studies in Pulmonary hypertension, Interstitial lung diseases, Lung transplant, Interventional Pulmonology and COPD.
 
BENEFITS
 UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
 PPO medical plan, available day one at no cost for full-time employee-only coverage
 100% coverage for preventive healthcare-no copay
 Paid Time Off, available day one
 Retirement Programs through the Teacher Retirement System of Texas (TRS)
 Paid Parental Leave Benefit
 Wellness programs
 Tuition Reimbursement
 Public Service Loan Forgiveness (PSLF) Qualified Employer
 Learn more about these and other UTSW employee benefits!
 
EXPERIENCE AND EDUCATION
 
Required
 Education
 High School Diploma or
 Associate's Degree in medical or science related field or
 Bachelor's Degree medical or science related field and no prior experience
 
Experience
 2 years experience with High School Diploma or
 1 year experience with Associate's Degree
 
Preferred
 Licenses and Certifications
 (BLS) BASIC LIFE SUPPORT may be required based on affiliate location requirements.
 (CPRAED) CPR AED may be required based on affiliate location requirements.
 
JOB DUTIES
 Understands visit schedules, criteria and protocol requirements for low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits.
 Assists research staff by completing research protocol related tasks.
 Reviews and abstracts information from medical records including eligibility criteria.
 Enters data into case report forms or other data collection system based on research study. Assists with maintenance of study level documentation.
 Assists with data queries and possible edits for accuracy.
 Compiles data for regulatory requirements and /or deadlines for local or sponsor submissions.
 Maintains existing databases and ensures data integrity.
 Performs QA/QC clinical analysis and data checks using various databases based on trial.
 Assists with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO).
 Assist and prepare research records for formal sponsor audits or internal audits.
 Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.
 With adequate training and supervision, assists with participant screening and recruitment for more complex trials.
 Conducts and documents consent for participants in studies. Assists with the development of consent plans and documents for participants.
 Identifies incomplete, inaccurate, or missing data for more complex studies and works with lead coordinator to correct errors.
 Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order.
 With adequate training and supervision, assists with collecting and processing specimens following established procedures/protocols.
 Assists in preparing studies for closeout, (e.g. packing files, documenting files for storage, shipping extra supplies back to sponsor).
 With adequate training/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKG's needed for research study. Based on research study, other procedures/equipment/services may be required.
 May perform patient care (basic skills) under the direction of PI following scope of work document.
 Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
 Performs other duties as assigned.
 SECURITY AND EEO STATEMENT
 
Security
 This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
 
EEO
 UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.

Clinical Research Assistant II, Internal Medicine Pulmonary

Yale University

<div>Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community, eligible for opportunities through the New Haven Hiring Initiative, or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale!
Overview
Working at Yale means contributing to a better tomorrow. The mission of the Yale Alzheimer&rsquo;s Disease Research Unit (ADRU) is to make advancements in treatment for Alzheimer&rsquo;s disease and related disorders that lead to early diagnosis, delaying of disease progression, and ultimately, a cure. We aim to achieve these goals through collaborative efforts between participants, their study partners, researchers, and clinicians. We are committed to conducting high quality and impactful research, educating research trainees, and caring for our research participants and their families. We are seeking a Clinical Research Coordinator (CRC) for the Yale ADRU to coordinate observational studies and therapeutic trials for individuals with normal cognition and symptomatic or presymptomatic Alzheimer&rsquo;s disease, and other cognitive disorders. Primary duties include managing clinical trial operations under the direction of the Principal Investigator and ensuring adherence to protocols, regulatory standards, and GCP guidelines. The CRC may participate in recruitment, informed consent, screening, and scheduling visits. Other primary duties include administering standardized cognitive tests and questionnaires to participants and their study partners, and performing clinical assessments such as vital signs, venipuncture, and electrocardiograms. The CRC is responsible for maintaining research records, including source documents and case report forms, entering data into electronic data capture systems, reporting adverse events, providing sponsors with requested clinical and regulatory information, and resolving data queries in a timely manner. Laboratory responsibilities may include coordinating laboratory specimen collection, storage, and shipment and maintaining laboratory equipment and supplies. Other responsibilities include managing study supplies, drug accountability, and assisting with monitor visits. The CRC may assist with the preparation of research protocols, and protocol renewals and amendments for submission to the investigational review board (IRB). The ADRU also has C&amp;T and post-baccalaureate study coordinators. The CRC may share in the training and supervision of these individuals and will generally serve as the lead coordinator of multi-coordinator studies. 
Required Skills and Abilities 
1. Clinical Research Proficiency and Compliance: Proven experience with clinical studies. 
2. Self-Motivation, Organization, and Detail-Orientation: Demonstrates self-motivation, independence,
consistency, and reliability. Shows excellent attendance, punctuality, and organizational skills. Pays close attention to detail and communicate effectively. 
3. Effective Under Pressure with Communication and Leadership: Proven ability to work efficiently and independently under pressure, prioritizing tasks effectively. Demonstrates strong oral and written communication skills, along with leadership qualities. 
4. Technical Proficiency in Research Tools: Exhibits proficiency in Microsoft Office, Experience with electronic data collection tools such as iPads and software like XXXXX.
Preferred Skills and Abilities:
Research experience with Alzheimer's disease and related disorders
Principal Responsibilities 
1. Compares protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols. 2. Documents established congruency between funding proposals and approved protocols. 3. Facilitates and/or assists with resolution of any inconsistencies between funding proposals and approved protocols. 4. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner. 5. Attends meetings and presents issues when necessary that were identified during congruency review. 6. Serves as a resource and provides technical assistance to investigators and their staff. 7. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed. 8. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements. 9. Develops, implements, and manages internal practices that ensure compliance with federal requirements. 10. May perform other duties as assigned. Required Education and Experience Bachelor&rsquo;s degree in a relevant academic/scientific field and a minimum of 3 years of related research support experience; or the equivalent combination of education or experience.
Job Posting Date
04/09/2026
Job Category
Manager
Bargaining Unit
NON
Compensation Grade
Administration &amp; Operations
Compensation Grade Profile
Supervisor; Senior Associate (23)
Salary Range
$65,000.00 - $101,000.00
Time Type
Full time
Duration Type
Staff
Work Model
On-site
Background Check Requirements
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit &quot;Learn about background checks&quot; under the Applicant Support Resources section of Careers on the It's Your Yale website.
Health Requirements
This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working a healthcare setting who have the potential for direct or indirect exposure to patients, human research subjects or infectious materials including body substance, contaminated medical supplies, devices and equipment, surfaces, or air. HCW have specific health requirements that must be met prior to starting work, including MMR vaccine or immunity, varicella (chickenpox) vaccine or immunity, TB screening, COVID vaccine according to University policy, hepatitis B vaccine or immunity, and annual flu vaccination.
Posting Disclaimer
Salary offers are determined by a candidate&rsquo;s qualifications, experience, skills, and education in relation to the position requirements, along with the role&rsquo;s grade profile and current internal and external market conditions. 
The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the position. Employees will be assigned specific job-related duties through their hiring department. 
The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual&rsquo;s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran. 
 
Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).
Note
Yale University is a tobacco-free campus.</div>

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