Title: Sr. Clinical Trial Associate
Location: Summit, NJ
Schedule: 8am to 5pm Mon – Fri.
Start date: ASAP
- 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.
- 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.
- 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.
- Computer skills - MS office suite
- 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
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
Attention To Detail
Complex Problem Solving