Clinical Research Coordinator - National Harbor, MD

Requirements

• Coordinates with Principal Investigator, department, and administration to ensure clinical research and related activities are performed in accordance with Federal Regulations and sponsoring agency policies and procedures.
• Reviews and comprehends the protocol.
• Collaborates with the PI to prepare Institutional Review Board (IRB) and other regulatory submission documents as required by the protocol.
• Establishes and organizes study files, including regulatory binders, study specific source documentation, and other materials.
• Assists PI in communication of study requirements to all individuals involved in the study.
• Conducts or participates in the informed consent process, including interactions with the IRB and discussions with research participants.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Coordinates participant tests and procedures, draws blood or collects urine sample for laboratory testing as specified by the protocol.
• Collects data and performs assessments specified in the protocol; vitals, questionnaires, EKG, photos.
• Maintains study timelines, maintains adequate inventory of study supplies, and completes study documentation and maintains study files in accordance with sponsor requirements.
• Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
• Maintains effective and ongoing communication with sponsor, research participants, and PI during the course of the study.
• Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies and the sponsoring agency.

Benefits

• 401K
• PTO
• Vacation
• Benefit Packages