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Senior Clinical Research Associate

Company: Actalent
Location: San Diego
Posted on: November 26, 2022

Job Description:

Description:Responsible for the day to day management of clinical trial sites across multiple clinical projects.Identifies and builds relationships with external clinical sites.Manages multiple clinical trials in parallel including investigator selection, analysis of potential enrollment, preparation of trial related documentation (protocols, case report forms, consent documents, letters of agreement, confidentiality agreements, etc.) and organize investigator's start-up meetings.Works with business development to contract external sites, as required.Submits protocols and other documents to Institutional Review Boards / Ethics Committees with follow through to ensure successful outcome.Monitors the assigned clinical trials following company SOPs and in accordance with GCP and all FDA and applicable international regulations concerning clinical trial activities.Assists in preparation of study-specific binders, logs and forms.Plans the requirements for clinical trial material, orders clinical trial material, sets up and monitors the systems whereby the clinical project coordinator can ship clinical trial material to the investigator, maintains procedures to account for the clinical trial material, checks the expiration of clinical trial material and requests extensions if necessary.Manages enrollment strategies to meet study requirements (e.g., investigator and study coordinator meetings, newsletters, advertising, etc.).Coordinates shipment of clinical samples and the resulting data when central laboratory facilities are used.Tracks completed CRFs and sets up systems whereby completed CRFs are rapidly entered into the database. Ensures that queries generated during data cleaning are responded to in a timely fashion.Evaluates clinical data/information and prepares reports as required.Participates in conference calls and meetings to review progress of ongoing clinical trials.Reviews all UADEs, ensures appropriate approvals are obtained, that sites are notified and that all company procedures are complied with.Maintains project files including: ethics committee approvals; curricula vitae of investigators and study personnel; package insert and user guides; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.Participates in the conduct of internal and external audits and inspections of clinical studies.Participates in departmental planning sessions, and SOP development.Mentors junior CRAs to promote departmental skill base.Skills:

  • 2+ years of Site Monitoring experience
  • Must have experience with in-vitro diagnostics
  • Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
  • Demonstrated ability to work independently with new, complex technologies and produce professional work products.
  • Strong written and verbal communication skills; demonstrated ability to organize and present scientific information (e.g., clinical study results) to internal and external audiences.Experience Level:Intermediate Level About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, San Diego , Senior Clinical Research Associate, Healthcare , San Diego, California

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