Sr. Research Program Coordinator
We are seeking a Sr. Research Program Coordinator (Sr. RPC) who will apply knowledge of clinical research practices and principles under the direction of the Sr. Research Program Manager or the Principal Investigator to ensure successful completion of each assigned clinical research study. The Sr. RPC will be responsible for a variety of activities for assigned research protocols including participant recruitment, data management, and protocol related clinical responsibilities. The Sr. RPC will work with patients at clinical visits to ensure the collection of required data and research samples.
Specific Duties & Responsibilities
- Conduct participant recruitment in compliance with research protocols.
- Perform clinical visits to administer questionnaires and collect patient samples.
- Ensure the proper entry, organization, maintenance and accuracy of all clinical and field research data in a timely and ongoing manner.
- Coordinate participant visits and follow-up, schedule appointments with study participants, and implement a multi-pronged communication approach to ensure required participant engagement, e.g., recruitment letters, reminders, tracking, etc.
- Recruit and screen potential study participants according to protocol’s inclusion and exclusion criteria
- Conduct phone and in-person interviews to determine study eligibility. Verify patient eligibility based on review of patient history and clinical laboratory results and knowledge of protocol requirements.
- For studies with a PRA, ensure participants meet all requirements, enter in a timely manner, and maintain participant changes in status as needed.
- Consent study participants, include physicians and/or advanced practice providers when needed. Upload and maintain consent forms per protocol and clinical requirements.
- Perform vital study procedures including venipuncture and collection of vital signs.
- Perform routine tests in a research laboratory.
- Process and store research samples as required, which may include the use of a centrifuge and freezing samples. After DOT/IATA training, will be responsible for shipping research samples to central labs as required.
- Enter data into sponsor-specific electronic data capture (EDC) systems or REDCap for investigator-initiated studies.
- Respond to queries in a timely manner and consult with manager, as needed, to resolve any issues.
- Ensure timely processing of participant payments as needed
- Design and maintain organizational tools to conduct the study accurately and in compliance with good research practice.
- Develop and maintain appropriate databases for current and future studies.
- Create and maintain database to optimize study analysis including enrollment and follow-up. Regularly review and quality control data
- Participate in weekly research progress meetings to report on recruitment progress, participant issues, and study status
- In collaboration with the manager or PI, manage tasks related to IRB compliance, e.g., protocol submissions, completing progress reports, tracking renewal dates, completing adverse event forms, writing draft forms.
- Maintain inventory of study related supplies and re-order supplies as needed
- Maintain organizational tools to conduct the study accurately and in compliance with good research practice.
- Responsible for general maintenance of the laboratory, equipment, supplies, storage, shipping and receiving of specimens and transport of specimens.
- Temperature monitoring of research sample freezers and scheduling centrifuge maintenance.
- Assist in training less experienced personnel in collection of data and samples.
- Design and compile materials to aid physicians and other staff in carrying out steps of study protocols.
- Assist in overseeing the duties of undergraduate researchers and less senior Research Assistants.
- Monitor data entry and patient binder completion by other staff members to ensure accuracy.
- Assist in the writing of post study data results and findings.
Additional Knowledge, Skills, & Abilities
- Ability to manage multiple and competing priorities.
- Knowledge of clinical research practices and principles.
- Knowledge of medical terminology.
- Familiarity with medical procedures.
Technical Qualifications or Specialized Certifications
- Standard HIPAA courses must be completed and appropriate exams passed with necessary certification within two weeks of start date.
- EPIC training courses (if not already done) to be completed within 1 month of start date.
Minimum Qualifications
- Bachelor's Degree in related discipline.
- Three years related experience.
- Phlebotomy experience or willingness to be trained/certified.
- Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
- Experience with EPIC or a similar electronic patient records system.
- Experience with EDCs, REDCap, and query resolution.
Classified Title: Sr. Research Program Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $41,300 - $72,300 Annually ($41,300 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: Mon-Fri 8:30 am to 5pm (earlier on some days); occasional nights/weekends if needed for a stay (rare)
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: SOM DOM Pulmonary
Personnel area: School of Medicine