Job Title: Senior Clinical Trial Associate

Job Description

This position reports to the Director of Clinical Operations and will be responsible for executing delegated responsibilities related to trial start-up, execution, and closeout to meet expected and specified quality standards. The Clinical Trial Associate (CTA) will also ensure that all trial-related activities comply with SOPs, policies, and regulatory requirements.

Responsibilities

• Provide general administrative support to the Clinical Operations Department and assistance to Clinical Study Manager(s).
• Support clinical studies and the Clinical Operations Department in managing various administrative tasks such as generating agendas and minutes, maintaining study tracking, and corresponding with the Institutional Review Board (IRB) as necessary.
• Assist the Clinical Study Manager(s) with CRO/vendor oversight, study-specific documentation review, and quality control, including review of protocol, informed consent forms (ICF), study plans, study reference manuals, case report forms (CRF), etc.
• Play a key role in assisting Document Management with implementing trial master file (TMF) specifications, ensuring they align with program milestones.
• Assist in document filing in the electronic TMF and conduct quality reviews.

Essential Skills

• Clinical trial experience
• Clinical research expertise
• Experience with electronic Trial Master File (eTMF) and TMF
• Proficiency in Veeva systems
• Microsoft Office skills
• Knowledge of rare diseases
• Strong administrative skills
• Familiarity with clinical documentation
• Understanding of Good Clinical Practices (GCP)

Additional Skills & Qualifications

• A minimum of a Bachelor's degree
• At least 3 years of experience in pharmaceutical drug development and clinical operations
• Knowledge of the drug development process
• Understanding of International Council for Harmonisation - Good Clinical Practices (ICH-GCP)
• Good Documentation Practices (GDP)
• Compliance with FDA Code of Federal Regulations

Work Environment

The role requires one day on-site in Pennsylvania, with the rest being work from home.

Pay and Benefits

The pay range for this position is $50.00 - $60.00/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 Bala Cynwyd,PA.

Application Deadline

This position is anticipated to close on May 9, 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.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.