Under the direct supervision of the PH Program Supervisor or the PH Program Principal Investigator, the Pulmonary Hypertension Research Program Coordinator will be the primary coordinator for multiple NIH, industry and Johns Hopkins initiated research projects. The PH RPC will be responsible for all aspects of implementation including IRB submissions, participant recruitment and education, scheduling and study visits which include administering questionnaires, study procedures and collecting and processing patient samples. The PH RPC will also be responsible for the organization, CRF completion, data entry, maintenance and accuracy of all participant clinical and research data and billing in a timely and ongoing manner.
Specific duties & responsibilities:
- Coordinate participant visits and follow-up, schedule appointments with study participants, make telephone reminders, track and locate participants.
- Ensure that proper written informed consent from each study participant is obtained prior to entering study; ensure that the original signed and dated consent from each study participant is filed in participants’ research record.
- Supervise or perform vital study procedures such as venipuncture, sample collection, vital signs, EKG and administration of 6 Minute walk tests (6MWT).
- Create and maintain database for study analysis including enrollment and follow-up.
- Recruit and screen potential study participants according to protocol’s inclusion and exclusion criteria; be knowledgeable of the protocol so that study activities are completed correctly and completely.
- Participate in weekly progress meetings of current research projects to report on recruitment progress and resolve problems.
- Assist in developing and maintaining appropriate databases for current and future studies.
- Conduct interviews over the phone or in person to determine interest and eligibility for a research study.
- Provide assistance to the administrator in tasks relating to IRB submissions: completing progress reports, tracking of renewal dates, completing adverse event forms, writing draft forms.
- Prepare and submit required documentation for IRB and CRU reviews and reporting in collaboration with the Principal Investigator.
Special knowledge, skills, and abilities:
• Solid understanding of research methodology, IRB, and GCP
• Experience with social and behavioral health interventions and/or qualitative research, preferred
• Ability to use personal computer; proficiency in Microsoft Office Suite; database and spreadsheet knowledge.
• Excellent oral and written communication skills and interviewing techniques.
• Detail oriented, strong interpersonal skills and excellent organizational and time management skills required.
• Carries out duties and responsibilities with limited supervision, but asks for clarification when needed regarding data quality and integrity issues and promptly notifies supervisors of any potential concerns regarding interactions with patients.
• Ability to function autonomously as part a collaborative interdisciplinary team
• Advanced problem-solving skills, ability to think quickly and implement plans/structure for accomplishing work
• Experience with placebo controlled pharmaceutical studies preferred
Technical qualifications or specialized certifications:
- Standard HIPAA courses and IRB course work must be completed.
Bachelor’s degree in related discipline
Some related experience
Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula