Job Description

Job Description

Job Description

Description:

ROLE

THE CLINICAL RESEARCH ASSISTANT (CRA) IS A SPECIALIZED RESEARCH PROFESSIONAL WORKING WITH AND UNDER THE DIRECTION SITE DIRECTOR AND CLINICAL PRINCIPAL INVESTIGATOR (PI). WHILE THE PRINCIPAL INVESTIGATOR IS PRIMARILY RESPONSIBLE FOR THE OVERALL DESIGN, CONDUCT, AND MANAGEMENT OF THE CLINICAL TRIAL, THE CRA SUPPORTS, FACILITATES AND COORDINATES THE DAILY CLINICAL TRIAL ACTIVITIES AND PLAYS A CRITICAL ROLE IN THE CONDUCT OF THE STUDY. BY PERFORMING THESE DUTIES, THE CRA WORKS WITH THE PI, RESEARCH TEAM, AND SPONSOR TO SUPPORT THE ADMINISTRATION OF THE COMPLIANCE, FINANCIAL, PERSONNEL AND OTHER RELATED ASPECTS OF THE CLINICAL STUDY.

RESPONSIBILITIES

• The CRA's primary responsibility, as with all clinical research staff, is to ensure the protection and well-being of the patients participating in the study. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI and sponsor to support and provide guidance on the administration of the compliance, financial, personnel, and other related aspects of the clinical study.
• oordinates with PI and the CRC to help ensure that clinical research and related activities are performed in accordance with federal regulations, site-specific policies and procedures, and sponsor required policies and procedures.
• Maintains effective and ongoing communication with the sponsor, research participants, CRC, and PI during the course of the study.
• Works with the PI and CRC to manage the day-to-day activities of the study, including problem-solving, communication, and protocol management.
• Reviews and comprehends the protocol, investigator brochures (when applicable), and all study-related manuals/guidelines.
• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
• Prepares other study materials as requested by the PI and CRC. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Prepares study-related documentation, including but not limited to source documents, adverse event reports, and progress notes.
• Establishes and organizes study files, including but not limited to study-specific source documentation and other materials.
• Attends investigator meetings as required or requested by the PI.
• Assists PI and CRC in communicating study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members—documents date of training and signatures of study personnel trained on the study-specific training log.
• Works with the PI and the CRC to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
• Conducts or participates in the informed consent process, including interactions and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Conducts or assist the PI or CRC with procedural aspects of studies, including standards of care, informed consent procedures, or documentation procedures.
• Conducts or assist the PI or CRC with screening subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
• Coordinates participant tests and procedures.
• Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Maintains study timelines.
• Assist the CRC or maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Clinical Trials Center of Middle Tennessee, LLC SOP on Investigational Drug/Device Accountability.
• Completes study documentation and maintains study files in accordance with sponsor requirements and Clinical Trials Center of Middle Tennessee, LLC policies and procedures, including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Retains and maintains all study records, including but not limited to case report forms, drug dispensation records, or regulatory forms in accordance with sponsor requirements and Clinical Trials Center of Middle Tennessee, LLC policies and procedures.
• Coordinates appropriate and timely payments to participants (if applicable) in accordance with Clinical Trials Center of Middle Tennessee, LLC policies and procedures.
• Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
• Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem-solving efforts such as protocol revisions.
• Coordinates and facilitates monitoring and auditing visits.
• Collaborates with PI and institution to respond to audit findings and implement approved recommendations.
• A great CRA possesses excellent verbal and written communication skills. Ensure Participant Understanding: When communicating with participants, the CRA should be able to explain a complex research protocol at the patient's level of understanding

TOOLS FOR SUCCESS

The Anatomy of a Great Clinical Research Coordinator

-anatomy-of-a-great-clinical-research-coordinator/

Job Tags

Similar Jobs