TIDEWATER PHYSICIANS MULTISPECIALTY GROUP P C
Location
Newport News, Virginia
The Clinical Research Coordinator manages the daily operations of clinical studies, including patient enrollment, protocol compliance, and data collection. They also handle laboratory specimens, maintain regulatory documentation, and coordinate with investigators and sponsors to ensure study success.
Candidates must hold a bachelor's degree and possess one to two years of related experience or training. Strong organizational skills, proficiency in medical terminology, and the ability to manage multiple responsibilities are essential for this role.
Understand clinical trials and specific requirements of each study to effectively develop recruitment strategies necessary for successful enrollment of trials. Identify, contact and schedule suitable patients for Clinical Trials, ensuring the potential candidates meet the eligibility criteria. Exceptional communication and interpersonal skills, a deep understanding of assigned clinical trials and a passion for healthcare are essential for effectively explaining the procedures and benefits of clinical trials to patients. Maintain thorough records of all recruitment activities and patient information by entering and updating the status of all potential subjects in the appropriate Excel sheets, portals and/or databases as required. Working closely with the Physicians, Clinical Research Coordinators and other team members to meet recruitment targets and adhere to ethical standards Effectively navigate Electronic Medical Systems and databases to assess patient eligibility. Work with the Marketing Department to develop advertising and other informational materials to be used in subject recruitment. Assess eligibility of potential subjects through review of medical records, screening interviews, and discussion of patient status with physicians and nurses. Organize study equipment and supplies. Attend meetings required by research sponsors; some travel and overnight stays may be required. Enroll patients in clinical studies, ensuring that informed consent is obtained and documented in accordance with all applicable regulatory and ethical requirements at the federal, state, and local levels. Schedule subjects for appointments or procedures as required by study protocols. Order the drugs and/or devices necessary for studies. Dispense medication and/or medical devices, calculate dosages, and provide instruction for patients as necessary. Handling lab specimens which may include blood, urine, vaginal fluids, joint aspirants, sputum or others, as required for the trials. Competent in the processing, and labeling of specimen tubes, filling out requisitions, working with dry ice, storing and shipping lab specimens as required. Collect and maintain study data, which may be either electronic and/or printed, depending on the study. Obtain subject follow-up information and communicate with health care providers and subjects as necessary. Prepare and maintain records of study activities, including case report forms, drug dispensation records, and regulatory compliance. Prepare and maintain study-related protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. Record adverse events and side effect data and confer with investigators regarding the reporting of events to oversight agencies. Track enrollment status of subjects, document causes of dropout, and document efforts to contact subjects. Become familiar with relevant electronic medical records and HIPAA law and comply with these. Monitor studies to ensure compliance with protocol design. Monitor studies to ensure compliance with federal, state and local regulations and TPMG's ethical policies. Prepare for and participate in audits conducted by study sponsors, federal agencies, and specifically designated review groups. Maintain contact with sponsors to schedule and coordinate site visits and answer questions about all issues with records or data. Participate in training and quality assurance programs. Ability to work well independently and with a team. Ability to refocus attention easily after multiple interruptions and remain organized despite multiple paper charts being utilized at the same time. Using your own transportation to purchase dry ice for laboratory specimen shipments and taking the packages to USPS, UPS, and or FedEx for delivery as needed. Willing to perform work related tasks off-site when necessary. Willing and eager to learn new things. Other duties as assigned.
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