Starting salary $45,000 (commensurate with experience)
S/he is responsible for coordinating and assuring integrity of all activities associated with conducting a clinical research study. S/he will ensure compliance with local, state, and/or federal regulatory requirements.
• Coordinates and assures integrity of all activities associated with conducting a clinical research study as it relates to compliance with local, state, and/or federal regulatory requirements.
• Assists Principal Investigators in the preparation and submission of clinical protocols, consent forms, and other documents to the scientific review committee, IRB and other regulatory organizations.
• Maintains regulatory files in compliance with regulatory requirements.
• Communicates with research participants, staff, regulatory affairs and data management groups, laboratory and clinical investigators, management, and outside collaborators.
• Recruits, interviews, and conducts study visit activities with clinical research volunteers, and obtains informed consent.
• May collect and analyze data to evaluate research participant eligibility for enrollment.
• Assists with the documentation and reporting of adverse events, completes and reviews Case Report Forms for patient eligibility, protocol compliance, omissions, errors, and submits these forms as required.
• Prepares and maintains written and electronic volunteer databases/logs.
• Perform data extraction and chart reviews of patients' medical records.
• Ensures that research records are stored and secured properly, and that inventory and records are updated and properly maintained.
• Conducts data verification as indicated, documents, assists the investigator and protocol coordinator with questions, may transcribe and resolve queries of data in case report forms (hardcopy or electronic).
Non Primary Responsibilities:
• Other duties consistent with the above responsibilities.
Knowledge, Skills and Abilities: Excellent communication skills, organizational skills and proficiency in research conduct are required. Knowledge of standard qualitative and quantitative data collection techniques; ability to follow general instructions; work in a team; good communication, writing and analytical skills; familiarity with social science research methodology is required. Ability to follow detailed instructions. S/he must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
Minimum Education/Training Requirements: Bachelor's Degree or higher is required.
Minimum Experience: 2-3 years clinical trial experience required. Prior experience within the DoD/VA systems of care strongly preferred. Expertise and experience in the field of cardiology is desirable.
Physical Capabilities: Must be able to sit and stand for long periods of time. Must be able to carry light items – up to 25 lbs.
Work Environment: Office and clinical environment.
McGuire Research Institute (MRI) is a non-profit organization, associated and located within the McGuire Veterans Administration Hospital, in Richmond Virginia. This is NOT a government position. MRI is an EEO and ADA compliant employer.