Clinical Research Associate II

Clinical Research Associate II Medical Device Field | Offers Benefits Job DescriptionJoin our team as a Clinical Research Associate, where you will provide support to the field-based team for site identification, feasibility, monitoring, site management, and study close-out tasks in compliance with Good Clinical Practices and applicable regulations. The role focuses on ensuring the quality and timely submission of documents and data from study sites, as well as mentoring in-house team members in clinical trial conduct.Responsibilities

• Facilitate site identification and feasibility assessments for clinical studies.
• Monitor clinical study sites and ensure compliance with protocols, regulations, and SOPs.
• Maintain electronic Trial Master Files and ensure quality documentation.
• Develop and review regulatory documentation for study start-up activities.
• Conduct training for site personnel and ensure resource adequacy.
• Report adverse events and ensure proper follow-up.
• Communicate deviations from protocol and implement corrective actions.
• Resolve data clarification forms and assist with investigator meetings.
• Manage regulatory documents and study supplies throughout study lifecycle.
• Prepare and review study-related tracking systems and ensure consistency.
• Obtain IRB approvals and renewals for the duration of the study.
• Participate in cross-functional team meetings to identify risks and propose mitigation measures.
• Generate and disseminate study status reports per project metrics.
• Participate in departmental development initiatives and continuous improvement processes.
• Collaborate with Finance, Accounting, and Clinical Trial Management to release payments based on site performance.

Essential Skills

• Minimum of 2 years experience as a Clinical Research Associate, ideally 4-5 years.
• Bachelor's degree required.
• Strong understanding of ISO, GCP, ICH, FDA and other applicable regulations.
• Experience in document control including TMF, protocol, and ICF revisions.
• Proficient computer skills, particularly in MS Office (Word, Excel, PowerPoint).
• Core understanding of medical terminology and clinical trial activities.

Additional Skills & Qualifications

• Attention to detail and strong organizational skills.
• Effective communication and problem-solving abilities.
• Ability to manage multiple tasks independently.
• Capability to travel up to 50-75% for monitoring visits.

Work EnvironmentThe role requires travel to sites for monitoring visits, with approximately 50-75% travel expected. The position involves working in a dynamic environment where priorities may shift, and independent initiative is valued. The team fosters a supportive atmosphere aimed at achieving project success. Job Type & LocationThis is a Contract position based out of Exton, PA. Pay and BenefitsThe pay range for this position is $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 & LocationThis is a Contract position based out of Exton, PA. Application DeadlineThis position is anticipated to close on Nov 26, 2026. Workplace TypeThis is a fully remote position.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 actalentaccommodation@actalentservices.com 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.