Job Title: Clinical Trial Associate

Job Description

This position reports to the Director of Clinical Operations and is responsible for executing delegated responsibilities related to trial start-up, execution, and closeout to expected and specified quality standards. The Clinical Trial Associate (CTA) will ensure all trial-related activities are in compliance 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 the generation of agendas and minutes, maintaining study tracking, and correspondence with the IRB as necessary.
• Assist the Clinical Study Manager(s) with CRO/vendor oversight, study-specific documentation review and QC, including review of protocol, ICF, study plans, study reference manuals, case report forms (CRF), etc.
• Play a key role in assisting Document Management with implementing TMF (trial master file) specifications, ensuring they align with the program milestones.
• Assist in document filing in the electronic TMF and quality reviews.

Essential Skills

• Experience in clinical trials and clinical research.
• Proficiency in eTMF and TMF.
• Familiarity with Veeva and Microsoft Office.
• Knowledge of GCP (Good Clinical Practices).
• Administrative skills and experience in clinical documentation.

Additional Skills & Qualifications

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

Work Environment

This position requires one day on-site in the person, PA. Consultants will have the option to go in more days if needed. The company is at the forefront of developing treatments for rare diseases, particularly the person's ataxia. Their lead candidate has shown promising results in clinical trials and has received significant backing from the FDA, including the lifting of a partial clinical hold and inclusion in the Strategic Targeted Approach for Rare Disease Therapies (START) pilot program. This support can accelerate drug development and approval processes. The company maintains a healthy cash position, which supports ongoing research and development efforts.

Pay and Benefits

The pay range for this position is $38.00 - $50.00

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 will be accepting applications until Jan 3, 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 for other accommodation options.

Salary : $38 - $50