Clinical Trial Associate

Clinical Trial Associate

The Clinical Trial Associate supports the planning, execution, and delivery of clinical trials in alignment with internal standard operating procedures, ICH/GCP guidelines, and applicable regulatory requirements. This role works closely with the Clinical Operations study management team to ensure efficient study management, adherence to timelines and budgets, and consistently high-quality standards. The position is a 6-month contract with potential conversion to full-time employment.

Responsibilities

• Create and review study plans, specification documents, study materials, and operational tools to support effective trial conduct.
• Support outsourced activities to Clinical Research Organizations (CROs) and other third-party vendors for assigned study tasks.
• Track study progress in the clinical trial management system (CTMS), including site activation, patient enrollment, patient status, and oversight of regulatory documents for site initiation and closeout.
• Deliver and execute day-to-day operational tasks and assist in tracking study metrics, maintaining and distributing study trackers, and ensuring data accuracy.
• Collaborate with clinical trial sites to build strong working relationships and support the collection and management of study materials and documentation.
• Review study documents for completeness, accuracy, and compliance with the protocol and applicable regulations, identify issues, and initiate appropriate corrective actions.
• Assist in preparing and reviewing study-related documents such as informed consent forms (ICF), clinical trial tools, templates, training materials, manuals, and study newsletters.
• Support project meeting logistics, including calendar management, room and equipment setup, collation of meeting materials, and attendance tracking.
• Work with the Clinical Trial Manager to prepare meeting agendas and draft, finalize, and distribute meeting minutes.
• Provide quality control oversight of CRO deliverables, trial master file (TMF) content, monitoring visit reports, payments, safety alert acknowledgments, informed consent forms, protocol amendments, and study closeout activities.
• Build and maintain strong professional relationships with vendors and colleagues across all cross-functional levels of the organization.
• Track payments to vendors and study sites as appropriate, ensuring timely and accurate processing.
• Oversee TMF quality review for the study team and complete TMF quality control for the department on a quarterly basis for each study, including collecting, reviewing, and submitting documents to the TMF.

Essential Skills

• Bachelor's degree in life sciences or a healthcare-related field.
• Minimum of 2–5 years of experience in a relevant field such as clinical site, CRO, sponsor, or clinical trial vendor, with sponsor experience preferred.
• Working knowledge of ICH GCP regulations and clinical protocols.
• Strong computer skills, including proficiency with Smartsheet, Excel, Word, PowerPoint, SharePoint, Veeva, and Outlook.
• Sound analytical and problem-solving skills, with the ability to act with a strong sense of urgency.
• Proven effectiveness in resolving complex site management issues.
• Strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines.
• Ability to work in a fast-paced environment and manage multiple competing tasks and demands with agility.
• Excellent written and verbal communication skills.
• Demonstrated ability to work as a collaborative team player who takes initiative and supports continuous improvement in ways of working.
• Experience in clinical trial operations, clinical research, clinical documentation, and clinical operations processes.

Additional Skills & Qualifications

• Experience partnering with Clinical Operations study management teams and cross-functional stakeholders.
• Familiarity with clinical trial management systems (CTMS) and trial master file (TMF) processes.
• Experience working with or overseeing CROs and other clinical trial vendors.
• Ability to build strong professional relationships with study sites and external partners.
• Comfort with creating and refining study tools, trackers, and documentation templates.
• Experience supporting meeting logistics, including agenda preparation and minute taking, in a clinical trial setting.

Work Environment

This role operates in a dynamic clinical development environment that emphasizes collaboration, quality, and adherence to regulatory standards. The position is primarily onsite in Wayne, PA, with an expectation of working in the office two days per week. The work involves regular use of office productivity tools and clinical trial systems such as Smartsheet, Excel, Word, PowerPoint, SharePoint, Veeva, Outlook, CTMS, and TMF platforms. The environment is fast-paced and deadline-driven, requiring strong organizational skills and the ability to manage multiple priorities while maintaining high-quality documentation and effective communication with cross-functional teams, vendors, and clinical trial sites.

Job Type & Location

This is a Contract position based out of Wayne, PA.

Pay and Benefits

The pay range for this position is $43.00 - $47.00/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 Wayne, PA.

Application Deadline

This position is anticipated to close on Jul 16, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 View email address on click.appcast.io for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.