What are the responsibilities and job description for the In- House Clinical Research Associate position at Actalent?
Senior Clinical Research Associate (In-House)
We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our growing biotech team. The ideal candidate will take a leading role in managing site start-up activities, collaborating with various teams, and ensuring compliance with regulatory requirements. This position offers an opportunity to work in a dynamic and remote-friendly environment.
Responsibilities
- Lead site start-up activities including oversight of CRO start-up activities and review of essential document packages.
- Collaborate with the contracts team to review and negotiate site and vendor budgets/contracts.
- Contribute to the development and review of study, patient, and site-facing documents, such as protocols and study plans.
- Oversee CRO monitoring activities, including visit schedules and monitoring plan reviews, and provide training support as needed.
- Review and oversee site KPIs, protocol deviations, and metrics to ensure data quality and compliance.
- Support the Trial Manager by tracking regulatory submissions, approvals, recruitment, and enrollment.
- Proactively review electronic data capture systems to identify issues and generate queries.
- Contribute to drafting SOPs and ensure studies are 'inspection ready' at all times.
- Collaborate with internal teams to ensure seamless trial execution and provide regular study updates.
- Support onboarding and mentoring of new department members.
Essential Skills
- Vendor management experience.
- Study start-up and monitoring oversight experience.
- Experience with site contracts, budgets, and management.
- Trial master file management.
Additional Skills & Qualifications
- At least 4 years of relevant clinical operations experience with a BS or BA in Life Sciences.
- Minimum of 4 years of independent on-site monitoring experience, with at least 3 years in a pharmaceutical sponsor environment.
- Excellent attention to detail and strong verbal, written, interpersonal, and presentation skills.
- Familiarity with medical/scientific terminology.
- Proficiency with MS Office.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs is desirable.
- Ability to participate in strategic initiatives.
- High energy level and a desire to work in a fast-moving, dynamic start-up environment.
Work Environment
This role is primarily remote, with occasional travel required (10-20%). Candidates ideally located in New England or comfortable working remotely in EST or CST time zones are preferred.
Job Type & Location
This is a Contract to Hire position based out of Boulder, CO.
Pay and Benefits
The pay range for this position is $52.00 - $62.00/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 Nov 14, 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.
Salary : $52 - $62