Clinical Research Assistant
About The Position
The Clinical Research Assistant (CRA) supports the accurate, efficient, and compliant conduct of new and ongoing clinical research studies under general supervision and the direction of the Principal Investigator (PI) and research team. Duties include participant recruitment and screening, study documentation, data collection and entry, scheduling, and administrative support. Responsibilities vary according to study assignment, training, and delegated duties. The role supports day-to-day study operations, regulatory and compliance activities, data management, specimen logistics, research billing review, and collaboration with internal and external research partners. The assistant works with study participants and research staff while maintaining participant confidentiality and following study protocols, institutional policies, SOPs, ICH-GCP, HIPAA, and applicable regulatory requirements.
Requirements
- 0–2 years of clinical research experience.
- Bachelor’s degree required.
- Strong interpersonal, communication, and organizational skills.
- Ability to manage multiple tasks, meet deadlines, and adapt to a fast-paced research environment.
Nice To Haves
- General experience working in clinical research, public health, or behavioral science is preferred.
Responsibilities
- Support day-to-day conduct of new and ongoing clinical trials under the direction of the PI and research team and in accordance with study protocols.
- Screen potential participants and collaborate with the PI, Clinical Research Nurse, or Clinical Research Coordinator for final candidate approval.
- Assist with scheduling and coordinating study visits, procedures, and related activities.
- Conduct timely telephone follow-up calls with participants and document communications according to protocol.
- Track enrollment, study milestones, outstanding tasks, and visit requirements.
- Assist with study supplies, laboratory kits, equipment, and other materials.
- Prepare documents and materials for study initiation, monitoring, and close-out visits with sponsors or CROs, including clerical support and information gathering.
- Assist with preparing and submitting regulatory documents to the Institutional Review Board.
- Organize and maintain regulatory and essential study documentation according to ALCOA+ principles and study requirements.
- Help prepare for sponsor/CRO monitoring visits, audits, and regulatory inspections.
- Perform assigned work according to study protocols, institutional policies, SOPs, ICH-GCP, and applicable regulatory requirements.
- Obtain medical records and other source documents needed for CRFs and study documentation.
- Assist with study data collection, entry, verification, and maintenance in EDC systems and other designated databases.
- Upload study-related images and imaging data to designated study imaging portals.
- Assist with data query resolution and follow up on outstanding data issues.
- Maintain study trackers, screening and enrollment logs, visit logs, and other assigned records.
- Prepare and organize research laboratory kits and materials.
- Coordinate research specimen collection, processing, storage, and delivery.
- Process, prepare, package, and ship blood, saliva, tumor tissue, and other research specimens according to protocols, laboratory requirements, and shipping procedures; assist with research-related pickups and deliveries on hospital and campus locations.
- Maintain documentation and tracking of research specimens and study materials.
- Attend study-related meetings, conference calls, training sessions, and other research activities.
- Work collaboratively with CRCs, CRNs, PIs, and other research team members.
- Communicate and collaborate with internal partners, sponsors, CROs, laboratories, IRBs, and other external research partners as directed.
- Assist with email correspondence, document preparation, copying, filing, and other clerical and administrative duties.
- Identify routine study-related issues and promptly communicate concerns to the appropriate research team member.
- Provide organizational and administrative support to facilitate efficient clinical research operations.
- Maintain participant confidentiality and comply with HIPAA, institutional privacy policies, and applicable research requirements.
- Assist with review of research billing charges, including UB-04 and CMS-1500 forms, for participants enrolled in clinical research studies.
- Assist in distinguishing research-related charges from standard-of-care services that may be billable to insurance or another responsible payer.
- Support research billing review activities as assigned and appropriately trained.
- Perform other duties as assigned or delegated by department leadership.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
