Clinical Research Coordinator

Overview

The CRC is responsible for managing and conducting clinical research projects by leading overall trial operations, collecting data, informing study participants about study objectives, administering questionnaires, ensuring FASMA SOPs are followed and working closely with the sponsor/CRO.

Coordinate research and administrative procedures for the successful management of clinical trials

• Coordinate research and administrative procedures for the successful management of clinical trials
• Ensure SOPs are followed
• Perform diverse administrative duties pertaining to clinical research
• Manage trial operations
• Monitors study activities to ensure compliance with protocols and with relevant local, federal, and state regulatory, institutional policies, and FASMA SOPs.
• Have an in-depth knowledge of protocol requirements.
• Act as liaison between the investigators, medical providers, the Institutional Review Board (IRB), CRO and sponsor.
• Maintain required records of study activity including Case Report Forms (CRFs), source, narrative notes, drug dispensing records, and all regulatory forms.
• Track enrollment status of subjects and document withdrawal information such as withdrawal causes and subject contact efforts.
• Input and upload subject information and pertinent clinical data to study-specific databases and/or EDC sites and FASMA CTMS within the appropriate timeframe defined by the protocol, sponsor, and SOPs.
• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians, nurses, medical assistants, and other staff. Enter potential subject demographics into FASMA CTMS.
• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
• Record and report serious adverse events to the sponsor or other regulatory authorities within the appropriate reporting guidelines and timeframe.
• Prepare, participate, and document quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Identify protocol problems, inform investigators of problems, and assist in problem resolution efforts such as protocol revisions.
• Manage the inventory of equipment and supplies related to each study. This includes ordering of Investigational Product (IP), temperature recording devices, calibrations, and all necessary supplies for study completion.
• Prepare study-related documentation such as protocol worksheets, source, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Maintain complete regulatory files and Investigator Site File (ISF). This includes completing all appropriate subject logs, screening and enrollment logs, study product/IP accountability logs, training documents, filing all applicable documents, correspondence etc.
• Completes and submits IRB initial, renewal and closure applications.
• Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, and documentation procedures.
• Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. Communicates with laboratories or investigators regarding laboratory findings.
• May assist with contracting with local vendors such as local laboratory.
• Reviews scientific literature and participates in relevant education activities to maintain knowledge of clinical studies affairs and issues.
• Maintains Good Clinical Practice (GCP) certification and all other project specific certifications.
• Maintains accurate and legible records, following ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) principles
• Manages site specific research staff CV’s, licenses and applicable trainings (i.e. GCP, IATA, etc.)
• Ensures site has all appropriate credentials and certifications (i.e. IATA, CLIA, etc.). If applicable, with approval, assist with renewal or apply for appropriate credentials and certifications.
• Acts as…