CLINICAL RESEARCH ASSISTANT

The Clinical Research Assistant (CRA) will assist in the conduct of clinical research activities, including participant recruitment, study documentation, data collection and entry, scheduling, and administrative tasks.

This position will work closely with, and under the direction of the Principal Investigator (PI) and research team and will perform duties consistent with training and assigned responsibilities, and delegation. 

Other responsibilities include participating in research team meetings, communicating with internal and external research team members, and providing organizational and operational support for new and ongoing clinical research studies. 

Under general supervision, the Clinical Research Assistant will assist research staff with a variety of tasks to support the accurate, efficient, and compliant conduct of clinical research studies.

Responsibilities may vary based on study assignment, training, and delegated responsibilities.

Study Operations: 

Support the day-to-day conduct of new and ongoing trials under the direction of the Principal

Investigator (PI), research team and in line with the protocol.  

Screen potential participants for research studies and collaborate with the PI, Clinical Research Nurse (CRN), or Clinical Research Coordinator (CRC) for final approval of the potential study participant as a candidate for the study 

Assist with scheduling and study visit coordination, including preparing for and supporting study visits, procedures, and other study-related activities 

Conducts timely telephone follow-up calls with study participants and document communications in the appropriate place in accordance with the protocol 

Assist with tracking enrollment, study milestones, outstanding tasks, and visit requirements 

Assist with study supplies, laboratory kits, equipment, and other study materials 

Assist with the preparation of documents and materials needed for study initiation, monitoring and close-out visits with sponsors and/or Clinical Research Organization (CROs), including clerical support, copying, and gathering information 

Regulatory & Compliance:

Assist with the preparation and submission of regulatory documents to the Institutional Review Board (IRB)  

Assist with organizing and maintaining regulatory and essential study documentation in accordance with ALCOA+ principles and study requirements, as directed by Supervisor, CRN, or CRC 

Assist the research team in preparation for sponsor/CRO monitoring visits, audits, and regulatory inspections 

Perform assigned responsibilities in accordance with study protocols, institutional policies, Standard

Operating Procedures (SOPs), ICH-GCP, and applicable regulatory requirements 

Data Management: 

Obtain medical records and other source documentation required to complete CRFs and study documentation 

Assist with study data collection, entry, verification, and maintenance in Electronic Data Capture (EDC) systems and other designated databases 

Assist with the upload of study-related images and imaging data to designated study imaging portals  

Assist study teams with data query resolution and follow-up on outstanding data issues 

Maintain study trackers, screening and enrollment logs, visit logs, and other study-related records as assigned 

Study Logistics & Specimen Management: 

Prepare and organize study 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 in accordance with study protocols, laboratory requirements, and shipping procedures, assist with hospital and campus research-related pickups and deliveries 

Maintain appropriate documentation and tracking of research specimens and study materials 

Collaboration and Support 

Attend study-related meetings, conferences calls, training sessions, and other research activities  

Work collaboratively with CRCs, CRNs, PIs, and other members of the research team 

Communicate and collaborate effectively 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 as requested by CRC, CRN, or Supervisor 

Assist with identifying routine study-related issues and promptly communicate concerns to the appropriate member of the research team 

Provide organizational and administrative support to research staff to facilitate the efficient conduct of conduct clinical research studies 

Maintain participant confidentiality and comply with HIPAA, institutional privacy policies, and applicable research requirements 

Perform additional duties as assigned in support of clinical research operations 

Research Billing & Compliance 

Assist with the review of research billing charges, including UB-04 and CMS-1500 (Form 1500) billing forms, for participants enrolled in clinical research studies 

Assist with 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 

Other Responsibilities 

Perform other duties as assigned or delegated by department leadership