Recruitment and Enrollment:
- Conduct study eligibility screening, recruitment, interviews and evaluation of potential study participants per IRB-approved study protocols.
- Obtain informed consent, collect and maintain subject data.
- Develop study recruitment materials and provide patient education regarding study specific requirements and expectations for participation.
- Coordinate clinical staff education to ensure collaboration on new processes that affect the clinic or hospital operations.
Research Coordination:
- Provide administration of study treatments, assessments and monitoring of participant health, participant education concerning protocol responsibilities and ongoing consent.
- Ensure participant and study compliance, i.e. collection of study specimens, and completion of study visits and research procedures within required study windows.
- Complete timely collection, labeling, processing, storage, transport and shipping of biological specimens per IATA requirements.
Data Coordination:
- Perform scientific and clinical data collection, through patient interaction, clinical observation and electronic health record review.
- Maintain detailed records of studies conducted, organize and prepare data for input into a variety of internal and external systems.
- Create and file adequate source documentation, ensure timely data reporting, and perform quality checks.
Troubleshooting:
- Collaborate effectively with other departments to ensure proper progress and completion of study procedures.
- Develop strategies to ensure increased study awareness and subject enrollment.
- Order and maintain supplies required for study kits, track spending in this area, and make day-to-day decisions in support of the study.
Compliance and education:
- Responsible for ensuring compliance with federal regulations for human subject research, University policies, and sponsor expectations as well as for continuing education relevant to their role.
- Maintaining current human subject research training, attending relevant educational seminars, and professional development in clinical research operations.
- Supports the orientation and training of new research team members, including faculty, residents/fellows, and other staff.
Knowledge, Skills & Abilities:
- Phlebotomy certified.
- Ability to multitask with excellent organizational skills.
- Excellent written and verbal communication skills; Skilled in interacting and working with others; including, peers, patients, management, internal and external stakeholders.
- Ability to work under minimal guidance and use independent judgment to determine best approach.
