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Sr. Clinical Trial Associate

Townsend & Associates Summit Contractor
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Sr. Clinical Trial Associate
Responsibilities:

  • Involved in the conduct of the study and interfaces with the Study Manager and the Study Team.
  • Responsibilities will vary slightly based on whether the study is insourced or outsourced, phase of the study lifecycle (start up, maintenance, close out).
  • MVR Review.
  • ICF Review.
  • IP Reconciliation.
  • Invoice and Payment review, approval and reconciliation.
  • Creating and or reviewing study plans, specification documents, materials and tools (diary cards, visit assessment booklets, etc).
  • Ability to communicate clearly both verbally and written to sites, vendors, CROs, internal study team, etc.
  • Track study progress in CTMS including patient enrollment and patient status,
  • Oversight of Regulatory documents for site initiation.
  • Provide access to systems when applicable. Track and ensure training of study team.
  • QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.
  • Process and track payments to vendors and study sites as appropriate.
  • Oversee TMF Quality Review for study team, complete TMF QC for department on a quarterly basis for each study Collecting, quality review and submitting documents to the TMF. Performing QC of TMF as appropriate.
  • Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors.
  • Generate, finalize and distribute study team agendas and meeting minutes.
  • Assist with generating the CSR appendices and participate in SOP and WP development.

Sr. Clinical Trial Associate

Sr. Clinical Trial Associate


W2 ONLY!!!


Qualifications:

  • Completed BA/BS in directly-relevant discipline or equivalent experience required.
  • At least 3 years' experience as CTA (or comparable operating experience) in pharmaceutical, or CRO required.
  • Candidate should have experience with insourced and outsourced studies. However, experience with Ph 1/2 insourced studies with focus on Hem/Onc and I&I would be best suited for this role.
  • Computer skills - MS office suite.
  • CTMS skills.
  • Sponsorview skills.
  • Knowledge of databases (EDC, IVRS, Central Lab, Central IRB).
  • Efficient at meeting planning / generating minutes.
  • Understanding / familiarity with drug development and process and Pharma.
  • Familiarity with ICH / GCP and regulatory guidelines/directives.
  • Proficient at Vendor / site payment process.
  • Knowledge of medical/scientific terminology.

Sr. Clinical Trial Associate

Recommended skills

Irb
Taking Meeting Minutes
Reports
Product Quality Assurance
Agenda Development
Pharmaceuticals
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Since our inception in 1999, Townsend and Associates aims to be the staffing firm both clients and professionals turn to first. Our core competencies in project staffing and full time placements are being continuously improved to be the best in class. Our markets will be solely determined by our ability to consistently deliver unequalled service to our customers and candidates.


Employers

Staffing your company with qualified and talented professionals is both challenging and time-consuming. Our goal is to make sure we understand your needs and the needs of our candidates. We research, screen and interview our consultants and employees, so we can provide you with the industries finest talent. This is why more and more companies decide to partner with Townsend & Associates, Inc.

Candidates

Townsend & Associates, Inc. offers you the opportunity to work with Fortune 1000, small and medium companies for full-time or contract positions. We work together with you and our clients to create an ideal match. We discuss your career objectives, talent, experience, and what you are looking for in a new job.

Our screening research is 2nd to none. By being thorough and straight forward, we cut through a lot of challenges that arise in many job searches. So whether it’s full-time or a contract position let Townsend & Associates simplify and enhance your journey.

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