In House Clinical Research Associate - Scientist
San Diego Metro Area, California
- BA/BS degree required.
5+ years of progressively responsible clinical operations experience; including project management and study team management.
Maintains up-to-date professional skills through formal training.
5+ years experience in global project management for Phase 2-3 studies.
Experience in managing CRO's, specialty labs and third-party vendors.
Must have prior monitoring or CRA experience performing on-site visits or accompanying monitors on site visits
Must have a broad multi-disciplinary understanding of the pharmaceutical drug development processes.
Strong knowledge of GCP's, ICH guidelines and study management skills.
- The Clinical Research Associate will directly supervise study management activities for the Company s clinical efforts. This is a team focused role working directly with other clinical and regulatory professionals, including working with CROs (Contract Research Organizations) involved in the Company s clinical efforts, and integrating those efforts with other departments within the Company.
Responsibilities and Duties:
Assists with establishing and maintaining study budget and timelines.
Serves as the primary project lead for communication and coordination of third-party vendors, escalating issues to Senior Management as appropriate.
Coordinates the execution of outsourced Global Phase 2 and 3 Clinical trials.
Coordinates and supports clinical team meetings and Vendor Team meetings.
Under the supervision of the Clinical Trial Manager or Associate Director, supports the management and oversight of CROs and other clinical study related vendors.
Assists with management of vendors working directly with Receptos. Under the supervision of the Clinical Trial Manager or Associate Director, manages project contracts, including finalization of initial task order and subsequent amendments, forecasting, assessment of work performed and appropriate site/vendor payments.
Directs study teams to identify and manage critical path activities such as selection of countries and sites, selection and management of vendors, development of risk management plan, CRF development, EDC system development, study portal setup, study monitoring, safety reporting, IRB/regulatory submissions and approvals, and study status reporting.
Apprises Clinical Trial Manager and Associate Director of all critical path activities and provides routine updates for all activities related to projects assigned.
Manages and oversees the performance of the study team to include third-party vendors and Regional CRAs/In-house CRAs.
Participates in the development, review and implementation of protocols, amendments, eCRFs, Guidelines, Monitoring Plans and Tools, IBs, Clinical Study Reports, abstracts and presentations, departmental SOP's and processes.
Supports the management of Investigational Product supply and distribution.
Manages the overall review of the clinical database and data listings to ensure that accurate data is delivered in a timely manner.
Supports the training of internal and external project team members (including CROs) on Good Clinical Practice, and other study-related activities from study initiation throughout the duration of the project.
Contributes to the development and implementation of policies and procedures regarding study related activities.
Performs monitoring oversight visits to review conduct of CRO and site staff.
Under the oversight of the Clinical Trial Manager or Associate Director, leads the process for the ensuring oversight of monitoring activities and review of monitoring reports. Performs trending of monitoring report and protocol deviation findings and recommends corrective and preventative actions, as applicable.
Oversight of TMF set-up, ongoing quality review and oversight of cross functional QC of TMF, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance,
May be responsible for review and approval of vendor invoices, as applicable.
Responsible for setting and meeting clinical goals and objectives.
Other responsibilities as assigned.