QC Research Associate

Highly Competitive Salary
  1. Permanent
  2. Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP)
  3. United States
Santa Monica, USA
Posting date: 17 Jul 2020
QA.CN.30670

Proclinical is currently recruiting for a QC Research Associate with a biopharmaceutical company located in Santa Monica, CA.

Job Responsibilities:

  • Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols.
  • Participates in protocol review discussions concerning scientific and procedural aspects of study design.
  • Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision.
  • With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
  • With supervision, addresses questions regarding scientific and related procedural issues from Investigators.
  • With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
  • Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
  • Supports priorities within functional area.
  • Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
  • May be asked to coordinate teams and provide direction.
  • May lead two or more specific components of departmental strategic initiatives.
  • Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
  • May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
  • Troubleshoot instrumentation/test methods. Lead/coordinate QC and cross-functional projects with limited direction.
  • Leads the training of QC staff. Independently plans and executes assigned experiments that support routine development activities and project goals.
  • Writes and revises methods, specifications, and SOP's as needed.

Skills and Requirements:

  • Knowledge of clinical trial design
  • Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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