Clinical Research Asst

3 weeks ago

Washington, Washington, D.C., United States MEDSTAR HEALTH Full time
Under the direct supervision of the Manager, the Clinical Research Assistant will support the facilitation and conduct of departmental clinical research efforts and support the clinical research team by performing a variety of research, database and administrative duties in support of clinical trials to ensure adherence to protocols and quality of information received. Required to enter study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.
Education
  • High School Diploma or GED or equivalent required and
  • Associate's degree or an allied health professional degree preferred
Experience
  • Prior work experience not required
  • 2 years experience in related field preferred and
  • Experience managing multiple priorities preferred
Knowledge, Skills, and Abilities
  • Verbal and written communication skills.
  • Basic computer skills preferred.
Contributes to the achievement of established department goals and objectives and adheres to department policies, procedures, quality standards and safety standards. Complies with governmental and accreditation regulations.Assists the clinical research team with Institutional Review Board (IRB) submissions as applicable; ensures the appropriate delegation of study related tasks (i.e., Delegation of Authority).On-site support of scheduling research participant visits; calls or sends reminders to research participants for scheduled visits.Accurately updates and maintains data entries into case report forms (CRFs) and the Clinical Trial Management System (CTMS) within one (1) business day; incorporate applicable source documents (e.g., surgical reports, pathology reports, medical history).Obtains and records ancillary service reports (e.g., x-ray, pathology, ECG, laboratory); completes all required clinical trial data fields as applicable and addresses all queries and clarifications; upholds data integrity in a high-quality, reliable and statically sound manner; completes and submits case report forms on as close to a Collects, processes and ships biospecimens and/or materials as applicable and according to each protocol; maintains current Occupational Safety and Health Administration (OSHA) training regarding Bloodborne Pathogens.Maintains International Air and Transportation Association (IATA) training for routine packaging, labeling and transporting of biological materials; maintains supply inventory (e.g., lab kits) and provides general support to the clinical research team including ordering and distributing non-drug clinical trial supplies.Assists the clinical research team in the preparation and on-site support of sponsor visits; works effectively with multidisciplinary, ancillary and inter-professional research teams; possesses a basic understanding of scientific center goals and the importance of serving our customers.Must comply with federal, state and sponsor policies; must comply with institutional policies, procedures and guidelines.Must possess basic understanding of the ethical treatment of research participants, aspects of human protection and safety in the conduct of clinical research, 21 CFR 50 Protection of Human Subjects, 21 CFR 54 financial Disclosure, 21 CFR 56 Institutional Review Boards.Required MedStar Health Research Institute trainings including but not limited to the Collaborative Institutional Training Initiative (CITI), Conflict of Interest (COI), annual MedStar Health mandatory's and Good Clinical Practice (GCP).Participates in multidisciplinary quality and service improvement teams as appropriate. Participates in meetings, serves on committees and represents the department and hospital/facility in community outreach efforts as appropriate.

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