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).
Job Purpose:
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
Duties/Responsibilities:
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 Delegation of Authority log. Coordinates local lab draws as needed. For post markets studies, this will usually only involve a finger stick. Acquires other lab requirements as necessary per protocol.
Manages the day-to-day activities of each study including trial operations, problem solving, communication, inventory control, and protocol management.
Maintain strict confidentiality and blinding protocol, if applicable, at all times.
Responds to study queries within appropriate timeframe defined by the protocol, sponsor, and SOPs.
Required Skills/Abilities:
Excellent attention to detail
Knowledge of biological and medical terminology
Understanding of the principles of administration and management
Superior organizational and time management
Capable of working independently and also as part of a team
Excellent verbal and written communication skills
Superior multi-tasking skills
Education and Experience:
Education: Preferable to have an Associate's degree in business administration, biology, health sciences, healthcare or any related field, or comparable clinical research industry experience.
Experience: Preferable to have a minimum of 2 years of Site Coordinating experience. Must have exceptional technical and communication skills. Candidate needs the ability to be proactive, multitask and maintain excellent organizational skills.
Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer.
Working in a fast-paced clinic setting assisting with patient visits and patient care
Must be able to lift up to 15 pounds at times.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)