Job Description

Job Title: Clinical Research Associate II

Job Description

The Clinical Research Associate II plays a pivotal role in the setup, activation, maintenance, and closure of global clinical trials. This position offers an opportunity to gain valuable experience in clinical trial management processes. The CRA II collaborates with Investigators, Site Personnel, and Vendors to ensure adherence to protocols and clinical objectives. Additionally, they maintain consistent CRF data quality and discrepancy interpretation across multiple sites while developing a foundational understanding of the disease and indication.

Responsibilities

• Participate in study design and setup activities.

• Prepare and review monitoring reports per SOPs.

• Support the development of study training and provide training to site personnel and internal employees.

• Assist in the development of CRF design, guidelines, and database development.

• Develop study tools and guidelines for use by study sites.

• Evaluate and select potential investigators, sites, and vendors.

• Interact with field monitors, CRAs, investigators, and study coordinators to manage study issues.

• Perform data entry and trend analysis in the clinical database.

• Draft informed consent forms and ensure compliance with GCP requirements.

• Coordinate and review regulatory documents from study sites.

• Track Safety Reports for assigned sites and ensure audit readiness.

• Author internal documents and contribute to clinical study and evaluation reports.

• Initiate device shipments and manage study supply inventory.

• Handle investigator contract, budget, and payment processes.

• Track quarterly site payments and reconcile study invoices.

• Communicate trial status to manager and team.

• Develop or revise SOPs or work instructions as needed.

• Represent the functional area appropriately.

Essential Skills

• Bachelor’s degree in a scientific field with a minimum of 2 years of experience in clinical research.

• Excellent verbal and written communication skills.

• High attention to detail and strong organizational skills.

• Basic understanding of peripheral and coronary artery diseases and therapies.

• Working knowledge of GCP, FDA, ISO, and other applicable regulations.

• Ability to travel 10-20% domestically and internationally.

• Experience with EDC Data Management Systems.

• Ability to manage multiple priorities in a fast-paced environment.

• Flexibility to work independently or as part of a team.

Additional Skills & Qualifications

• ACRP or SOCRA clinical research certification preferred.

• Experience with medical devices and cardiovascular studies is preferred.

• Proficiency in Excel, including pivot tables.

• Experience with Angio tracker and cardiac imaging.

• Familiarity with SmartSheets and SharePoint.

Pay and Benefits

The pay range for this position is $40.00 - $50.00/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 fully remote position.

Application Deadline

This position is anticipated to close on Oct 10, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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