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Clinical Trial Associate - NJ
Ref No.: 18-06074
Location: Summit, New Jersey
Position Type:Contract
Start Date / End Date: 05/14/2018 to 11/17/2018
Sunrise System Inc. is currently looking for Clinical Trial Associate in Summit, NJ with one of our top client.
Job Title: Clinical Trial Associate
Job Id: 18-06074
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, CRO, or healthcare environment(s) required.
  • 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.
  • The CTA also supports the Study Team by creating and distributing study team materials, tools and documents.
  • 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.
Responsibilities include, but are not limited to, the following
  • Creating and or reviewing study plans, specification documents, materials and tools.
  • 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.
  • Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives.
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, CRO, or
  • healthcare environment(s) required.
  • Computer skills - MS office suite
  • CTMS (TW, Celtrak)
  • Knowledge of databases
  • 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
  • Familiarity with ICH / GCP and regulatory guidelines/directives
  • Team player and ability to build relationships
  • Strong organizational skills
  • Proficient at Vendor / site payment process
  • Knowledge of medical/scientific terminology
  • Cross cultural awareness Key Competencies:
  • Commitment to quality
  • Works efficiently
  • Demonstrate adaptability and flexibility
  • Acts with integrity
  • Works independently
  • Shows work commitment
  • Prepares written communication
  • Uses technical / functional expertise
  • Fosters teamwork
  • Proactive behavior
  • Listens to others
Contact
Praful Prasanna
Email: Praful.P@sunrisesys.com | Direct: (732) 272 20326
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com