Senior Clinical Research Associate

Redwood City, CA 94063

Posted: 02/07/2020 Employment Type: Contract Job Number: 17109

Job Description


Bayside Solutions is seeking a Senior Clinical Research Associate  to be a part of our Client’ s team in Redwood City. Our partner is a biopharmaceutical company focused on the discovery, development and commercialization of medicines for patients in therapeutics areas.

Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

  You can find additional information on our company website at www.baysidesolutions.com.

 Senior Clinical Research Associate

Job Benefits:
  • The opportunity to work with a company that has products in the development pipeline, as well as a successful marketed product
  • Competitive compensation commensurate with experience
  • This position is eligible for medical, dental, vision, sick time, and 401K benefits

 Summary of Responsibilities:
  • Participate in development of project-specific documents (protocol, ICF), plans (e.g., Clinical Monitoring, Communication, Project Management, etc.), and other study-related documents (manuals, instructions, etc.)
  • Assist in development of Case Report Forms (CRFs)
  • Manage creation of study-related templates and logs by CRO
  • Manage investigative site selection process for clinical trials
  • Manage  external vendors that provide systems supporting clinical trial conduct (e.g., CTMS, EDC, IWRS, eTMF, etc.)
  • Coordinate and participate in Investigators’ Meetings
  • Train CRO CRAs on internal company processes
  • Conduct site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim monitoring visits, and close-out visits)
  • Review and follow-up on monitoring visit reports ensuring adherence to GCP/ICH
  • Manage investigational product accountability and reconciliation process
  • Prepare  internal and external memos, reports, documents, and correspondence required to properly manage and document activities on clinical studies
  • Assist in query resolution and data listings review process prior to the database lock
  • Coordinate the collection and management of clinical trial documentation to be filed in Trial Master File and Electronic Study Files
  • Collaborate internally
  • Participate in project team meetings and collaborate with other functional groups within the company (Clinical Development, Drug Safety and Pharmacovigilance, Biometrics, Clinical Research Compliance, Regulatory, QA, Pharmaceutical Operations, Legal, Medical Affairs, etc.) to achieve clinical study goals and timelines
  • Assist in preparation and QC of Clinical Study Reports 

 

Qualifications:
  • The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience, and knowledge, or the equivalent:

Minimum Requirements:
  • Bachelor’ s or higher degree in science, nursing, or equivalent with 3-5   years of experience in biotech, pharmaceutical, or CRO industry
  • Strong working knowledge of FDA and EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials 
  • Experience in site monitoring and oversight of contract service providers
  • Familiarity with pharmaceutical and medical terminology
  • Proficiency in Microsoft Word, Excel, PowerPoint, and Publisher
  • Experience with different EDC and IWRS platforms
  • Travel required (~10%)

Preferred Requirements:

Experience in international clinical trial operations

Meet Your Recruiter

Lissa Zamolo

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