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Clinical Trial Associate

New Jersey All, NJ

Posted: 03/01/2019 Job Type: Clinical Job Number: JN -032019-23824
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 include, but are not limited to, the following:
  • Support the Study Team to select potential investigators and assess their interest in the study
  • Communicate with the sites through direct contact and other tools such as newsletters as appropriate per study requirements
  • Track study progress in CTMS including patient enrollment and patient status
  • Process drug shipments after gathering necessary essential documents and track the receipt of shipments
  • Support study data as the EDC administrator and by tracking CRFs and queries as appropriate
  • Process and track payments to vendors and study sites as appropriate
  • Distribute and, at times, create study documents for the study sites such as CDAs, feasibility questionnaires, study binders, etc.
  • Review documents including essential documents and submit documents to appropriate departments such as IMSC, Regulatory Affairs, etc.
  • Maintain and track documents such as IB, insurance policies, documents that are expiring and IND safety letters using CTMS (or other tools)
  • Support the Study Manager in creating, updating and tracking MS Project study plans
  • 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 4 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

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