Clinical Research Coordinator

* Verifies investigator/site feasibility, facilitates site budget/contract approval process, and develop timelines for conducting and completing the trial, as well as manage financial agreements.
* Attends Investigator Meetings as required.
* Prepare and submit initial study submission to IRB/IEC and/or sponsor for review and approval.
* Select the investigational staff and assign roles and responsibilities, ensuring appropriate training of staff.
* Maintain trial master file (e.g., regulatory binder), Identify minimum regulatory document requirements for site trial master file (e.g., country-specific regulatory documents), while ensuring IRB/IEC review/approval of study and study documents.
* Develop and follow a recruitment strategy and study management plan, maintain screening/enrollment log and ensure trial subject retention.
* Select and manage local vendors (e.g., laboratory, x-ray, MRI), and maintain current vendor credentials (e.g., lab certification/licensure and normal ranges) as applicable.
* Prepare study documentation (e.g., schedule of events, description of procedures) as well as modifying per protocol amendments require.
* Search clinical databases for potential participants, and schedule participants for protocol specific procedures, including multi-department visits as indicated in protocol.
* Conduct informed consent, working with the participant's the trial Investigator and/or Primary Care Physicians to ensure the participant understands study design.
* Collect, record, and report accurate and verifiable data, conducts participant visits according to requirements, documenting protocol deviations/violations and implementing corrective actions plans as applicable.
* Enter and transmit data, as well as review and resolve CRF queries from the study monitor/data management.
* Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO ensuring timely review of study data (e.g., laboratory results, x-rays).
* Manage study supplies (e.g., lab kits, case report forms), equipment (e.g., calibration and preventive maintenance), and study record retention and availability.
* Coordinate study monitoring visits, including site initiation, interim and close-outs.
* Prepare study documents and study summary and/or close-out letter for IRB/IEC.
* Interrogate implantable cardiac devices (i.e. pacemakers, defibrillators).
* Analyze implantable cardiac devices, perform diagnostic tests, and make appropriate device programing changes.
* Ensure adequate site management, while being compliant with electronic data requirements (e.g., electronic health records, eCRF).
* Ensure access to source data by authorized parties, in accordance with ICH-GCP, and protect confidentiality by limiting unauthorized access.
* Respond to or facilitate response to audit/inspection findings.
* Ensure proper adverse event reporting by the investigator.
* Escalate problems to appropriate in-house management.
* Investigate and/or report potential fraud and misconduct.
* Ensure follow-up medical care for study subjects is documented, as applicable.
* Ensure staff, facility, and equipment availability throughout the study.
* Ensure compliance with study requirements and regulations.
* Assess participant safety during trial participation, by reviewing participant's medical records, as well as self-reported adverse events.
* Collaborates with physicians and nurses to coordinate a patient's plan of care to prevent duplication of patient services and to ensure continuity of care.
* Minimize potential risks to subject safety, oversee safety risks (e.g., clinical holds, product recalls), handle medical monitor oversight.
* Report required adverse events to Sponsor/CRO, regulatory authorities, and/or IRB/IEC, ensure proper documentation of adverse events, coding correctly (e.g., serious, severe, moderate, mild, expected, unexpected, and causality).
* Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts).
* Manage and motivate the investigational staff and other disciplines involved, and take measures to minimize any potential risks.
* Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit progress reports to the IRB/IEC per requirements.
* Review common laboratory values and alerts, review for potential subject safety issues (e.g., toxicity, significant lab values).
* Implement Investigator's plan of action for management of adverse event (e.g., stop investigational product; call, retest, treat subject).
* Maintain follow-up to determine resolution of adverse event.
* Document follow-up medical care for study subjects, as applicable.
* Conduct safety monitoring/reporting activities.
* Initiate un-blinding procedures.
* Evaluate and review protocol for feasibility, review protocol during Investigator's meeting.
* Possess knowledge of protocol development, submission, and approval process, including protocol amendment submission and approval procedures.
* Understand clinical trial…