Retina Sacramento MSO LLC
Clinical Research Supervisor (Project Management)
We seek a full-time Clinical Research Supervisor to support our clinical research department. Although you must be able to work independently, you will be working directly with physicians, patients, research coordinators, clinical and business office staff and with pharmaceutical sponsor representatives to correctly and efficiently execute clinical research protocols. Collaboration and being a team player are essential to the success of this role.
Responsibilities:
Responsible for overseeing day-to-day research activities, program operations, and administration.
Ensures clinical research studies are conducted efficiently and in compliance with FDA and GCP guidelines.
Oversees the recruitment, scheduling, and data-entry process for clinical research studies.
Maintains current knowledge of Federal, State, and institutional guidelines and requirements governing research.
Assists Department Regulatory Coordinator with the preparation and maintenance of regulatory documentation for submission for review by the Institutional Review Board (IRB) and other required review committees. This includes new, renewals, amendments, modifications, and revisions of protocols, descriptions of study, investigational drug information, HIPAA documentation and development of consent forms consistent with legal, Human Subjects Review Committee and Department of Health and Human Services (DHHS) requirements.
Coordinates and supports staff of site selection and startup activities such as: completion of site feasibility questionnaires, review of study protocols, preparation of clinical trial feasibility assessments, preparation of sponsor documents, coordination of pre-study site visits, preparation, distribution and completion of financial disclosures
Maintains site feasibility for ongoing and future studies.
Assists the Clinical Trial Manager and Principal Investigators in providing information to sponsors and vendors during study startup, conduct and closeout process.
Ensures the study site operates at RCA expected levels of service, timeliness, and accuracy.\
Supervises clinical research staff by setting goals, conducting regular meetings, and monitoring performances.
Assists the Clinical Trials Manager with study staff hiring, training, and annual evaluations.
Updates site study assignment log and trial master file in Google Drive.
Manages site protocol deviation tracking and ensures corrective action plans are implemented.
Evaluate team environment and implement team building activities.
Facilitates visits from sponsors, CROs, RCA and other stakeholders.
Initiates and oversees study site purchase order process for supplies and devices.
Provides weekly reports to the Clinical Trial Manager.
Participates in meetings with other supervisors and attends RCA annual National meetings and required training.