Clinical Research Coordinator, Clinical Translational Transplant Medicine - Georgetown University M

7 days left

Location
Washington D.C.
Posted
Jul 15, 2017
Closes
Aug 02, 2017
Function
Analyst, Research
Industry
Education, Research
Hours
Full Time
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Requirements

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.

Documentation

  • 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.

Data Collection

  • 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.

Close Outs

  • 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.

Requirements

  • 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.

Preferred qualifications

  • Perioperative drug and device research experience
  • Knowledge of database and statistical software
  • BLS certification
  • Phlebotomy experience

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Submission Guidelines:

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume  for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.

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EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff.  All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex, disability status, protected veteran status, or any other characteristic protected by law.