Clinical Research Coordinator, Clinical Translational Transplant Medicine - Georgetown University M
Clinical Research Coordinator, Clinical Translational Transplant Medicine - Georgetown University Medical Center
Clinical Research Coordinator, Center for Translational Transplant Medicine (CTTM), conducts a variety of clinical research studies, including clinical trials, federally funded clinical research, and investigator-initiated translational research in a variety of perioperative specialties, including but not limited to, gastroenterology, interventional radiology, and transplant surgery. S/he ensures that all protocol requirements and regulations for research are met. . The Clinical Research Coordinator has duties that include but are not limited:
Site Feasibility Assessments
- Facilitates site qualification visits at various MedStar Georgetown Transplant Institute Clinics.
- Maintains established departmental policies and procedures.
- Attends required meetings and participates in committees as requested.
- Under supervision of a physician and manager, prepares all regulatory documents in compliance with protocols, IRB submissions, and informed consents.
- Reports and forwards all amendments and adverse events to IRB and sponsor.
- Maintains communication with sponsors and manager.
Recruitment & Screening
- Assists investigators with pre-screening, recruitment, and screening, and selects patients for studies.
- Ensures that eligibility requirements and protocol compliance are met.
- Prepares patients for office procedures, and observes and documents research assessments, as appropriate.
- Under supervision of an investigator, performs enrollment assessments, including inclusion/exclusion criteria review, IVRS/IWRS randomization, and research assessments, which include reporting observations, outcomes, and adverse events.
- Conducts concurrent chart review of selected patient populations and assesses the appropriateness of the research-related care, diagnostic testing, and research procedures, under the supervision of a physician.
Coordination with the GU Clinical Research Unit, MedStar Research Health Institute (MHRI), and Other GU Shared Resources
- Communicates research plan of care with patients, families, medical staff, and care givers as appropriate.
- Assesses, plans, implements, and evaluates the research plan in conjunction with the patient and investigator.
- Advises investigators of research data needs and completeness of research documentation.
- Takes on-call research shifts, one week per month on overnight shifts and responds to paging 24/7/365 to support the needs of the transplant schedule.
- Produces source documentation in written or electronic format while adhering to good clinical practice guidelines.
- Independently collects, prepares, organizes, and enters data in case report forms and databases as appropriate within a contract's specified terms.
- Sends daily emails to research team tracking abdominal transplants, for cause biopsies, and scopes.
- Collaborates with staff within the department, as well as throughout the hospital, to obtain data and implement operational standards.
- Ensures confidentiality of data for all study subjects.
- Identifies issues/problems and makes appropriate recommendations for compliance to research billing and researches review of charges and collections appropriate to clinical trial.
- Communicates with patients, families, medical staff, caregivers, and third party payers, as necessary about financial responsibility for all aspects of medical regime.
- Obtains appropriate financial responsibility forms.
- Reconciles charges to third party payers versus clinical trials in conjunction with the clinical research operations office.
- Handles data collection and reporting for study participants.
- Performs quality control functions of assigned area, as directed.
- Maintains data tracking in accordance with various accrediting and governing bodies.
- Monitors all activity of on-site reviewers for consistency and correctness in the application of standards.
- Under supervision of the Director, prepares and schedules and audits with pharmaceutical sponsors and other monitors for trials.
- Maintains compliance with all research related requirements to ensure ongoing grant approvals.
- Establishes independent guidelines for protocol adherence in a study specific source or standard operating procedure.
- Reviews all patient medical records and data within the designated time frames and established guidelines, standards, policies, and procedures.
- Conducts close out visits and ensures that all sponsor, FDA, NIH, and foundational requests are met.
- Analyzes and abstracts data from the medical under the direction of Principal lnvestigator(s) for reporting to sponsors, governing bodies, and academic publication.
- Bachelor's degree in related field
- Preference for 2 to 3 years of experience in coordinating clinical research/clinical trials
- Excellent organizational and communication skills
- Ability work both independently and collaboratively on a team combined with MedStar Georgetown investigators, GU employees, MedStar hospital employees, clinical research operations office, and internal CTTM clinical research patients
- Familiar with good practice.
- Attention to detail, self-directed
- Computer proficiency and knowledge of Microsoft applications
- Ability to produce clear, error-free written and verbal communications to internal and external collaborators and regulatory agencies
- Knowledge of all applicable laws and regulations for research for clinical research, particularly good clinical practice
- Willingness and availability to the various MedStar Georgetown Transplant Institute clinics.
- Perioperative drug and device research experience
- Knowledge of database and statistical software
- BLS certification
- Phlebotomy experience
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