Clinical Trial Associate

$104,000 - $122,720/Yr

Actalent - Elizabeth, NJ

Full-time - Entry Level

Hybrid - Elizabeth, NJ

10,001+ employees

Administrative and Support Services

About the position

The Clinical Study Associate II role involves assisting in the planning and execution of clinical studies under the supervision of the Study Manager or Study Associate Manager. The position focuses on providing clinical trial management support, ensuring compliance with protocols, Good Clinical Practices (GCPs), and relevant regulations. The role includes tracking vendor performance and supporting study teams in various administrative tasks.

Responsibilities

• Reconcile the TMF document trackers generated by the CRO with the document archive and address issues with the reconciliation by proposing a remediation plan.
• Distribute key study documents to the CRO and vendors as appropriate.
• Provide clinical administrative support to the study teams, including preparing meeting logistics, distributing agendas, and minutes for study team meetings, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.
• Collect information and coordinate with Regulatory Operations to post trial information on required public forums (e.g., clinicaltrials.gov).
• Support Fair Market Value process in evaluating study budgets.
• Review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports, under supervision, and escalate issues to the supervisor.
• Compile and maintain a monitoring review spreadsheet.
• Compile and maintain CRO Oversight Monitoring (CROOM) visit output.
• Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities, and escalate areas of concern to the supervisor.
• Create and maintain spreadsheets to track various items as needed, such as vendor invoices.
• Analyze study site metrics reports to identify potential areas of concern and bring them to the supervisor's attention.

Requirements

• Knowledge of processes related to clinical studies, regulatory issues, assigned CRO operations, and compliance practices.
• Ability to interact appropriately with internal and external stakeholders (e.g., CROs and other team members).
• Foundational knowledge and application of compliance practices.
• Effectively manage information, data, related analyses, forms, and reports.
• Ability to support and multi-task different assignments and responsibilities.
• Problem-solving skills with the ability to escalate issues appropriately.
• Familiarity with medical terminology.
• Proficiency in computer applications such as Microsoft Word, Excel, PowerPoint, and Outlook.
• Basic oral and written communication skills.

Nice-to-haves

• Experience with managing an eTMF, preferably in a system such as Veeva Vault.
• Experience with meeting agendas and minutes, completing system access requests, CTMS systems, SharePoint site management, and maintaining study team lists and other study-specific trackers (e.g., 1572s, CVs, MLs, FDFs, GCP).
• Relevant experience in clinical or basic research in a Pharmaceutical company, Medical device/Diagnostic company, Academic Research Organization (ARO), or Contract Research Organization (CRO).
• Time spent directly in a medical environment (e.g., as a Study Site Coordinator) is considered relevant.
• A Bachelor's degree in Life Sciences with relevant clinical development experience is preferred.

Benefits

• Medical, dental & vision insurance
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan with pre-tax and Roth post-tax contributions
• Voluntary Life & AD&D insurance for the employee and dependents
• Short and long-term disability insurance
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Paid Time Off (PTO), Vacation or Sick Leave