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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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