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Sr. Clinical Trial Associate
Ref No.: 19-11931
Location: Summit, New Jersey
Sunrise System Inc. is currently looking for Sr. Clinical Trial Associate in Summit, NJ with one of our top client.
 
Job Title: Sr. Clinical Trial Associate
Job Id: 19-11931
Location: Summit, NJ 07901
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
 
Description
  • Completed BA/BS in directly-relevant discipline or equivalent experience required; and
    At least 3 years’ experience as CTA (or comparable operating experience) in pharmaceutical, or CRO.
  • Summary/Scope The Clinical Trials Associate (CTA) is 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).
  • Candidate should have experience with insourced and outsourced studies.
  • Experience with Ph. 1/2 insourced studies with focus on Hem/Onc and I&I would be preferred.
  • Responsibilities include, but are not limited to, the following:
  • 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.
Skills/Knowledge Required
  • 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.
  • Computer skills - MS office suite
  • Sponsor view
  • Knowledge of databases (EDC, IVRS, Central Lab, Central IRB)
  • Efficient at meeting planning / generating minutes
  • Understanding / familiarity with drug development and process and Pharma
  • Strong Verbal and written communications skills
  • Self-starter / proactive
  • Ability to work independently
  • Good listener / problem solver
  • Ability to prioritize and multi-task and demonstrate flexibility and attention to detail.
Contact
Chenchukala Alwar
Direct: 732-313-0243| Email: Chenchukala.A@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com