Clinical Research Assistant

Cooper University Hospital • Camden, NJ

8d

About The Position

The Clinical Research Assistant supports the accurate, efficient, and compliant conduct of new and ongoing clinical research studies under general supervision and in accordance with training, assigned responsibilities, delegation, and study protocols. The role works closely with the Principal Investigator and research team, providing participant recruitment and screening support, study documentation, data collection and entry, scheduling, and administrative and operational assistance. Duties may vary by study assignment, training, and delegated responsibilities.

The position assists with study operations, regulatory and compliance activities, data management, research logistics and specimen handling, research billing review, and collaboration with internal and external partners. The Clinical Research Assistant is expected to maintain participant confidentiality and follow HIPAA, institutional privacy policies, applicable research requirements, institutional policies, SOPs, ICH-GCP, and protocol requirements.

Requirements

• Bachelor’s degree required.
• 0–2 years of experience in clinical research.
• 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 clinical trials under the direction of the Principal Investigator and research team and in accordance with study protocols.
• Screen potential study 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 other study-related activities.
• Conduct timely telephone follow-up with study participants and document communications as required by the protocol.
• Track enrollment, study milestones, outstanding tasks, and visit requirements.
• Assist with study supplies, laboratory kits, equipment, and other study 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 preparation and submission of regulatory documents to the Institutional Review Board.
• Organize and maintain regulatory and essential study documentation in accordance with ALCOA+ principles and study requirements, as directed.
• Help prepare for sponsor/CRO monitoring visits, audits, and regulatory inspections.
• Perform assigned responsibilities in accordance with protocols, institutional policies, SOPs, ICH-GCP, and applicable regulatory requirements.
• Obtain medical records and other source documentation 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 study records as assigned.
• 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 study protocols, laboratory requirements, and shipping procedures.
• Assist with hospital and campus research-related pickups and deliveries and maintain documentation and tracking of 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, and communicate with internal partners, sponsors, CROs, laboratories, IRBs, and other external 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 (Form 1500) forms, for participants 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 when appropriately trained.
• Perform other duties as assigned or delegated by department leadership.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level