Clinical Research Coordinator

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 Foot and Ankle Specialists of the Mid-Atlantic (FASMA) Standard Operating Procedures (SOPs) are followed and working closely with the sponsor/Clinical Research Organization (CRO).

• 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.
• Has an in-depth knowledge of protocol requirements.
• Acts as liaison between the investigators, medical providers, the Institutional Review Board (IRB), CRO and sponsor.
• Maintains required records of study activity including Case Report Forms (CRFs), source, narrative notes, drug dispensing records, and all regulatory forms.
• Tracks enrollment status of subjects and documents withdrawal information such as withdrawal causes and subject contact efforts.
• Inputs and uploads subject information and pertinent clinical data to study specific study databases and/or EDC (Electronic Data Capture) sites and FASMA Clinical Trial Management System (CTMS) within appropriate timeframe defined by the protocol, sponsor, and SOPs.
• Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians, nurses, medical assistants, and other staff. Enters potential subject demographics into FASMA CTMS.
• Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
• Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.
• Records and reports serious adverse events to the sponsor or other regulatory authorities within the appropriate reporting guidelines and timeframe.
• Prepares, participates, and documents quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Identifies protocol problems, informs investigators of problems, and assists in problem resolution efforts such as protocol revisions.
• Manages 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.
• Prepares study-related documentation such as protocol worksheets, source, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Maintains 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 a contact liaison for study participants by answering questions and keeping them informed of study protocol.
• Communicates with manager with all pertinent study related progress, issues and when subjects have completed the trial.
• Arranges for secure retention of all study documents in accordance with sponsor requirements and site SOP, whichever is longer.
• Manage all locked areas where investigational or study products and supplies are stored.
• Tracks and maintains temperature and maintenance logs and/or devices for research related equipment.
• Draws blood or supervises the on-site drawing of blood as dictated by the research protocol. For delegated blood draws, document fully on the…