Job Title: Clinical Trial Administrator

Job Description

The Senior Clinical Trial Associate (Sr. CTA) is responsible for providing support and oversight for the planning, execution, and financial aspects of Phase I – IV clinical studies, working closely with and under the supervision of Clinical Trial Managers (CTM) and Clinical Operations leadership. The Sr. CTA will work with the CTM to provide oversight for any Sr. CTA activities performed or managed by partner Clinical Research Organizations (CRO).

Responsibilities

• Assist the CTM with achieving key study parameters including clinical study start-up activities, clinical supplies preparation, study execution, data collection, regulatory document management, vendor/CRO communication and management, and study close-out.

• Prepare and review study documents including clinical protocols and amendments, case report forms and source document templates, informed consent forms, site training materials, site regulatory binder, site pharmacy binder, and clinical study reports.

• Oversee day-to-day operational activities and specific projects within Clinical Operations, including communications with cross-functional teams and provision/review of project team meeting agendas and minutes.

• Set up and maintain electronic Trial Master Files (eTMF) in accordance with SOPs.

• Schedule, perform, and oversee ongoing reviews of eTMF to assure completeness and quality of the documentation/files and compliance with SOPs, GCP, and ICH Guidelines.

• Develop and review regulatory documentation to support study start-up activities, ensuring all site supplies are available for site initiation visits and sites are ready for activation and enrollment activities.

• Act as primary liaison for study sites and monitors to convey project information and answer questions in accordance with the CTM escalation pathway.

• Assist the project team in preparation for audits/inspections and ensure the quality and completeness of clinical trial documentation.

• Assist with planning and attend Investigator Meetings and study-specific training for assigned trials; present training as assigned.

• Collaborate with monitors to obtain/share trial-specific issues across all study sites, focusing on quality, site performance, and metrics.

• Communicate issues in accordance with the CTM escalation pathway to monitors or other project team members as appropriate.

• Develop and maintain collaborative working relationships with clinical investigative sites.

• Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned monitor.

• Liaise with Procurement, Legal, and Finance to secure confidentiality agreements, master service agreements, and clinical trial agreements; track all HCP/site invoices for Sunshine Act reporting.

• Monitor recruitment remotely through IRT, EDC, or other systems and/or communication with sites, and prepare metrics for the CTM/project team.

• Prepare and review various study-related tracking systems to determine and report the status of clinical trial documents and metrics related to trial milestones, timelines, and financials.

Additional Skills & Qualifications

• Experience presenting information to teams and team training/mentoring is a plus.

• Experience in various electronic data capture systems involving site enrollment and tracking is a plus.

• Minimum 2-3+ years of CTA/Sr. CTA experience from pharma/biotech or CRO.

• ETMF Experience.

• Familiarity with driving contracts through a process.

• Vendor management experience/exposure.

• Solution-oriented mindset.

• Open to any therapeutic area.

• Experience with trip report review and deviations is a plus.

• Global experience is a plus but not required.

Work Environment

The work environment is fast-paced and dynamic, requiring the ability to adapt quickly to changes. The role involves significant interaction with internal departments such as Medical, Data Management, Statistics, Regulatory Affairs, Pharmacovigilance, and Executive staff, as well as external consultants, clinical research organizations (CROs), vendors, and clinical site personnel. The position promotes from within and values mentoring and collaboration. The work environment may involve stepping into a rapidly changing setting where flexibility and a solution-oriented mindset are key.

Pay and Benefits

The pay range for this position is $45.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • 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 Parsippany-Troy Hills,NJ.

Application Deadline

This position is anticipated to close on Mar 14, 2025.

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.