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 phases, study design characteristics, (e.g., double-blind, crossover, randomized), and study objective.* Verify the eligibility of potential trial subjects, reviewing inclusion/exclusion as defined by the protocol.* Execute study per protocol, following description of procedures (e.g., vitals, blood collection, EKG).* Ensure proper collection, processing, and shipment of biological specimens (e.g., centrifuge, preparation of slides, freezing, and refrigeration).* Associates degree in healthcare discipline or relevant field required.* Bachelor's degree preferred. Will consider relevant work or educational experience.* Certified Clinical Research Coordinator (CCRC) required within 3 years of employment.* International Air Transport Association (IATA) Dangerous Goods Regulation (DGR) training required within 30 days of hire.* Collaborative Institutional Training Initiative (CITI) program certification required within 30 days of hire.* Current American Heart Association Basic Life Support (BLS) strongly preferred at time of hire, required within 3 months of hire.* Knowledge of research study design for clinical trials, Phase I - IV.* Knowledge of medical terminology, cardiac anatomy, physiology, and conduction system.* Knowledge of Good Clinical Practice (GCP) regulations/guidelines and federal regulations surrounding the conduction of human research.* Knowledge of HIPAA guidelines, legal and ethical considerations related to patient and company information.* Skill in effective written and verbal communication.* Skill in operating office equipment including a personal computer, EMR, practice management system, scanner/fax/copy machine, pager and telephone systems.* Skill in obtaining vital signs and performing phlebotomy services.* Skill in query resolution.* Ability to conduct trials under the direction of a Principal Investigator.* Ability to recruit and consent patients according to appropriate guidelines.* Ability to establish and maintain effective working relationships with those contacted outside of HC in the course of daily work.* Ability to organize time and materials effectively achieving department goals.* Ability to accurately type 40 WPM.* Ability to work collaboratively with physicians, managers, and other staff in a professional manner to promote effective team building. #J-18808-Ljbffr