Job Title: Clinical Study Associate II

Job Description

Assist in planning and execution of clinical studies, under the supervision of the Study Manager or Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Clinical Study Oversight Plan (CSOP).

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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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.

Work Environment

This position requires 1-4 days onsite in Basking Ridge, NJ.

Pay and Benefits

The pay range for this position is $50.00 - $59.00

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

Workplace Type

This is a hybrid position in Elizabeth,NJ.

Application Deadline

This position will be accepting applications until Dec 16, 2024.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.