Lead CRA

Job Title: Lead Clinical Research Associate

Job Description

The Lead Clinical Research Associate is responsible for overseeing the site management and monitoring activities of assigned clinical trials. This role ensures compliance with the study-specific Monitoring Plan, study protocol, applicable SOPs, ICH GCP, and regulatory requirements. The individual provides leadership, subject matter expertise, and operational support to CRAs throughout the lifecycle of a study, assessing CRA and site performance, and reviewing monitoring visit reports and metrics. Additionally, the role involves independent oversight of clinical monitoring activities performed by CROs/Monitoring Partners and/or third-party vendors to ensure compliance with ICH-GCP, applicable regulatory requirements, and SOPs.

Responsibilities

• Provide leadership, guidance, and support to CRAs on assigned clinical trials, ensuring study deliverables are met efficiently and with quality.
• Oversee and manage CRA teams and study sites from start-up to close-out.
• Develop or contribute to study-specific site management and monitoring tools and documents.
• Train CRAs on the study and maintain study training compliance.
• Assist in planning, tracking, and driving start-up activities by working closely with CRAs and study team members to maintain accurate site selection and activation timelines.
• Oversee and monitor the management of research sites, ensuring compliance with study plans through regular communication with CRAs, study teams, and vendors.
• Serve as the primary contact and resource for CRAs and other study team members.
• Assist in vendor management, ensuring site-specific vendor-related issues are promptly escalated and addressed.
• Review CRA monitoring visit reports to ensure quality and timely resolution of site-related issues and protocol deviations.
• Coordinate and perform quality and compliance assessment activities and support their resolution.

Essential Skills

• Expertise in clinical research and site monitoring.
• Strong leadership and team management skills.
• Proficiency in developing study-specific management tools.
• Ability to train and guide CRAs effectively.
• Experience in vendor management and issue escalation.
• Strong communication skills and ability to serve as a primary contact for study teams.

Additional Skills & Qualifications

• Experience in Oncology therapeutic area.
• Knowledge of ICH GCP and regulatory requirements.

Work Environment

This role operates within the Midwest and Eastern Time Zones.

This is a Contract position based out of Cambridge, MA.

The pay range for this position is $90.00 - $95.00/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)

This is a fully remote position.

This position is anticipated to close on Apr 10, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.