Clinical Trial Associate

Actalent; United States; Hybrid; USD 62.000 - 76.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account

Zusammenfassung

Actalent is seeking a Clinical Trial Associate to support the Clinical Operations team in Bala Cynwyd, PA. The role involves trial startup, execution, and closeout activities to ensure quality and regulatory compliance.

You will assist Clinical Study Managers, manage study documentation, and coordinate with CROs and vendors in a fast-paced environment. The ideal candidate has at least 3 years of pharmaceutical development and experience with ICH-GCP, TMF, and eTMF processes, plus proficiency in

Qualifikationen

• Bachelor's degree required.
• Minimum 3 years of pharmaceutical drug development and clinical operations experience.
• Knowledge of the drug development process and regulatory requirements.
• Understanding of ICH-GCP, GDP, SOPs and FDA CFR compliance.

Aufgaben

• Provide general administrative support to Clinical Operations and assist Clinical Study Managers.
• Support studies and manage tasks like agendas, minutes, study tracking, and IRB communications.
• Assist with CRO/vendor oversight, document reviews, and quality control of study materials.
• Help implement TMF specifications and conduct quality reviews of TMF documents.
• Assist in document filing in the electronic TMF and ensure compliance.

Kenntnisse

Clinical trial experience

Sponsor CTA experience

BLA submission

ICH-GCP familiarity

Ausbildung

Bachelor's degree

Tools

Veeva

Microsoft Office

Jobbeschreibung

Job Title: Clinical Trial Associate

Job Description

The Clinical Trial Associate will report to the Director of Clinical Operations and be responsible for executing delegated responsibilities related to trial startup, execution, and closeout to meet expected and specified quality standards. The role involves ensuring 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 Managers.
• Support clinical studies and manage various administrative tasks such as generating agendas and minutes, maintaining study tracking, and corresponding with the IRB as necessary.
• Assist Clinical Study Managers with CRO/vendor oversight, study-specific documentation review, and quality control, including review of protocol, ICF, study plans, study reference manuals, and case report forms (CRF).
• Play a key role in assisting Document Management with implementing TMF specifications to align with program milestones.
• Assist in document filing in the electronic TMF and conduct quality reviews.

Essential Skills

• Clinical trial experience
• Clinical research proficiency
• eTMF and TMF knowledge
• Proficiency in Veeva and Microsoft Office
• BLA Submission experience
• 3 years of Sponsor CTA experience, preferably with a small sponsor
• Sponsor experience (excluding embedded and CRO candidates)
• Supporting Inspection Readiness
• Site Management experience
• Data review experience
• Ability to operate in a fast-paced working environment

Additional Skills & Qualifications

• Bachelor's degree
• Minimum of 3 years of pharmaceutical drug development and clinical operations experience
• Knowledge of drug development process
• Understanding of ICH-GCP, GDP, SOPs, and compliance with FDA Code of Federal Regulations

Work Environment

Consultants will work one day on-site in PA, with the option to go in more days if needed. The company is at the forefront of developing treatments for rare diseases, with promising clinical trial results and significant backing from the FDA. This supportive environment is designed to accelerate drug development and approval processes.

Job Type & Location

This is a Contract position based out of Bala Cynwyd, PA.

Pay and Benefits

• $45.00 - $55.00/hr.
• Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
• 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)

Job Type & Location

This is a Contract position based out of Bala Cynwyd, PA.

Application Deadline

This position is anticipated to close on Nov 4, 2026.

Workplace Type

This is a hybrid position in Bala Cynwyd,PA.

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 [e-mail] 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.