Clinical Research Coordinator I - MPS

Responsibilities

• Writes protocol applications and consent forms for Institutional Review Boards.
• Prepares and submits required institution and federal documentation for the conduct of the research.
• Manages regulatory issues for all programs upon receipt of IRB approval.
• This includes preparing any addenda and/or annual progress reports, submitting adverse event/safety information to the IRB, updating/maintaining regulatory requirements such as updated investigator CVs, changes in principal investigator, etc.
• Maintains accurate, regulatory-compliant program/study documentation.
• Performs scientific literature searches, editing, and formatting in support of research efforts, and the distribution of manuscripts and reports to all scientific collaborators as required.
• Conducts research in collaboration with investigators and other staff to include interaction with study subjects for screening, recruitment and data collection, applying quality control measures as outlined/required by the protocol; contributing to the collection and organization of data; performing basic data entry and coding.
• Consent providers and patients into research studies following designated protocol.
• Adheres to compliance and privacy/confidentiality requirements and standards, including DOD specific regulations and guidance; develops and implements Standard Operating Procedures (SOPs) for research activities to ensure consistency, quality, and compliance.
• Performs administrative duties such as: assisting in maintaining study database and files; developing data collection packets; scheduling study appointments; maintaining team calendar, coordinating meetings while maintaining meeting documentations/agendas/minutes; provide data tracking updates for project meetings; processing/shipping study materials.
• May perform other duties and responsibilities as assigned or directed by the supervisor.

Qualifications

• Education and Experience: Bachelor's Degree required, preferably within Psychology or Sociology. Minimum of 0-2 years experience required. Preferably a minimum of 1 year of experience.
• Required Knowledge, Skills And Abilities: Knowledge of project management; well-organized. Ability to follow detailed instructions. Ability to handle multiple tasks. Ability to facilitate communication among supervisors, peers, and supervisees. Must be familiar with Institutional Review Board activities and applicable federal and military regulations regarding the use of human subjects in research. Must be able to set and meet deadlines. Interest in working in military mental health research. Ability to understand and utilize scientific terminology and research theory in both oral and written communications. Background in psychology, social work, or another health-related field preferred. Ability to obtain and maintain a T1/Public Trust background check.