Staff Research Associate I (Clinical Research Coordinator)

• Contributes to planning and organizing the clinical aspects of the research studies. Identify and coordinate with interdisciplinary departments involved with the implementation of the clinical study. Assist with providing in-services and support as needed for personnel involved with the care of subjects and research activities.
• Aid in the preparation and management of IRB submissions and reports. Maintain regulatory documents in compliance according to Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) procedures.
• Responsible for screening subjects to evaluate subjects' records to determine eligibility according to the protocol's criteria. Pl is responsible for final eligibility approval.
• Collects clinical data required by the study protocol. Maintain complete and accurate case report forms and source documentation for each subject enrolled. Correct data discrepancies/inconsistencies identified in a timely manner.
• Assist with documenting all significant study patient encounters in EMR, including appropriate clinical assessment and plan under supervision of PI and/or Research Nurse, ensuring the PI and/or Research Nurse is kept informed of all encounters and including the PI and Research Nurse as a co-signer on progress notes.
• Communication of all protocol-related issues/problems to the PI, Research Nurse and the sponsor. Assist with reporting serious adverse events promptly according to the protocol requirements and local IRB and SFVAMC R&D policies.
• Help to ensures that Study Drug or Device administration is completed per protocol. Maintain complete and accurate records of the receipt, dispensing, retrieval and return of Study Drug or Device.
• Aid in the coordination and participation in meetings, conferences, training sessions and other forums regarding the conduct of the clinical study, including national PI/ Study Coordinator meetings requiring travel. Help in the identification any barriers regarding recruitment, enrollment, and any other issues involving study activities.
• Contribute to the preparation and participates in quality assurance activities (monitoring visits, internal not for cause audits and sponsor audits).
• Ensure that all VA sensitive information is being used, stored and secured in accordance with the VHA policies and guidance.
• Assists with reimbursement submissions
• Maintains files documenting research trainings, credentials, research-related TMS certificates, CVs, licensing, certifications, memberships, and other related materials for each study team member and gives timely reminders and assistance as needed to maintain these and prevent expiration and provides evidence to sponsors and others requiring it.
• Scheduling of study sessions, meetings, phone calls, etc.
• Participate in the screening of potential study participants
• Maintaining reliable and regular contact with faculty, and keep PI apprised of study updates.
• Performs other related duties as assigned.

• Minimum Bachelor of Science and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities
• Previous experience in coordinating and conducting clinical research studies. Preference for conducting Cardiac Catheterization Laboratory clinical trials or similar experience.
• Knowledge of the code of federal regulations for conducting clinical research, GCP guidelines and SOPs.
• Prior extensive experience with phlebotomy, specimen collection, processing and shipping
• IATA certification or willingness to obtain within one (1) month of hire
• Willingness to learn IRB / SFVAMC R&D regulations and reporting requirements.
• Experience with study documentation and HIPAA regulations.
• Experience working with diverse teams of interdisciplinary administrators and clinicians with ease and professionalism to effectively coordinate study activities. Maintain professional conduct in the presence of subjects, clinical staff and sponsors.
• Ability to multitask and manage multiple projects, tasks and priorities to achieve desired goals.
• Required to have and maintain documentation of annual training in ethics of human subject research and GCPs.
• Ability to work under minimal supervision and meet deadlines
• Strong accuracy and attention to detail
• Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
• Proficiency with Microsoft Word, PowerPoint, and Windows.
• Excellent analytical and problem-solving skills.
• Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.
• Ability to establish cooperative working relationships with patients, co-workers, and physicians.

Northern California Institute for Research and Education