In this role you will be responsible for but not limited to the following:
*Please note this is not a laboratory tech position, and job duties do not include performing laboratory assays*
- Liaise with the present Study Coordinators to coordinate and execute sponsor and/or investigator-initiated clinical trials.
- Attain in-depth understanding of study protocols and objectives to assist with successful implementation of all study procedures. Coordinate recruitment of patients for pulmonary hypertension trials and patient education relative to study participation.
- Perform medical chart review, patient screening, informed consent processes, scheduling and conducting patient clinic visits, data processing, and diagnostic and therapeutic interventions.
- Directly interact with study patients in a clinical setting, act as liaison between patients, investigators, nurses, other departments, sponsors, vendors, and regulatory agencies.
- Manage patient research data accurately in an organized and timely manner; adverse event reporting; prepare appropriate reports for investigators and/or sponsors including maintaining and completing the supplied case report forms; project reports as required by study sponsors.
- Coordination and participation in site visits with the sponsor/CRO. Manage and coordinate data related to patient participation in studies, workflow as needed by multiple studies, and participate in maintaining regulatory files.
This position requires excellent written and oral communication skills. To be successful in this position the self-motivated candidate should have a working knowledge of Good Clinical Practice (GCP), as well as governmental and local regulations governing clinical research.
The candidate must demonstrate strong interpersonal skills with exceptional attention to detail. A successful candidate will also possess strong critical thinking, and organizational skills. Candidates must be able to meet multiple concurrent deadlines independently. The candidate must demonstrate project management ability and a positive approach and capacity to accept feedback and use it to improve individual and team performance. It is imperative in this position to be a pro-active team member and be willing to assist other team members as needed.
Independent knowledge, skills, and abilities within all 8 competency domains is expected:
1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork
Supervision Received: This position receives functional supervision from CRC Lead and reports directly to Faculty Principal Investigator, Dr. McLaughlin.
Supervision Exercised: None