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Job Title: Clinical Trial Associate
Duration: 6 Months
Location: Summit, NJ
Responsibilities will include, but are not limited to, the following:
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.
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
Demonstrate adaptability and flexibility
Acts with integrity
Shows work commitment
Prepares written communication
Uses technical / functional expertise
Listens to others
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