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.