||Clinical Research Coordinator A
||The Clinical Research Coordinator is responsible for managing clinical research activities. They will screen and enroll subjects ensuring they meet inclusion and exclusion criteria. Manage study related activities, ensure subject compliance and prepare documentation. The Clinical Research Coordinator will also monitor and report adverse events to the appropriate staff members as well as complete end of study regulatory documentation.
Under the direction of the Principal or Sub-investigator, manage the conduct of clinical research activities.
Develop management systems and prepare for study initiation:
• Assess study feasibility in terms of study's impact on site resources, labor cost, cost by procedure, potential for problems (such as serious AEs, noncompliance, willingness of subjects to participate, protocol deviations, etc.)
• Possess a comprehensive and in-depth understanding of each protocol that has been assigned as a primary responsibility;
• Review with the principal investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol;
• Review the protocol summary sheet and the informed consent form for accuracy and clarity;
• Develop source documents based on the most current IRB approved protocol and reviewed for accuracy and clarity;
• Develop a plan for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate.
Screen and enroll study subjects
• Review the study design and inclusion/exclusion criteria with the subject’s primary physician;
• Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility;
• Review the protocol, informed consent form, and follow-up procedures with potential study subjects;
• Ensure the current approved informed consent is signed before subjects are screened and enrolled;
• Ensure that the randomization procedure is followed as per protocol guidelines;
• Document protocol exemptions and deviations and report to IRB (as required).
Manage study related activities, subject compliance and documentation:
• Including related clinical duties such as performing EKGs, lab processing, and if not already qualified to perform phlebotomy – must acquire these skills.
• Ensure adherence to protocol requirements;
• Schedule subjects for follow-up visits;
• Assist investigators in assessment of subject response to therapy;
• Review laboratory data, inform investigator of abnormal values and document;
• Report to primary care provider as appropriate;
• Assess and document subject compliance with medications and visits;
• Communicate with pharmacy staff to assure timely and accurate study drug distribution;
• Manage administration of investigational therapy;
• Maintain dispensing logs (if allowed);
• Maintain copies any documentation for dispensing of investigational products and/or study-related supplies;
• Oversee specimen collection, storage, and shipment;
• Attend study-related meetings as appropriate;
• Communicate regularly with the principal investigator, monitor (others responsible for conduct of the research) about study-related issues.
Record data and study documentation
• Record data as directed using the appropriate media or platform;
• Follow procedures for access and security for electronic data entry;
• Review keyed data for accuracy as needed;
• Send data to the data collection center on a timely basis;
• Maintain source documentation for all data entered, including clinic chart visit notes, lab data, and procedure reports;
• Correct and edit data as directed and as appropriate.
Monitor and report adverse events
• Document and record all AEs as outlined in protocol with causality determined by PI or SI.
• Report serious adverse events (SAEs) to the principal investigator, sponsor, and IRB (others as required by funding source or as outlined in the protocol).
• Know and understand all regulatory requirements associated with the conduct of the study assigned;
• Maintain files and documents as regulations dictate;
• Prepare and submit initial applications to central and local committees (IRBs, biosafety, radiology, etc), prepare and submit reports as required;
• Ensure that all required documentation is complete and appropriately filed.
Management of site activities during audits and inspections
• Prepare for quality assurance audits and regulatory inspections as needed;
• Act as contact person before, during, and after audits and inspections;
• Provide all required documentation to auditors;
• Make all appropriate corrections as requested by auditors;
• Coordinate site response to audit / inspection findings.
Management of ancillary staff
• Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
• Training (appropriate to anticipated duties - nursing degree or diploma, other degree deemed suitable by the Director of Research such as Medical Assistant or Health Related Sciences).
• Experience in the conduct of clinical research preferred but not required for application.
• Interpersonal and communication skills - interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
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