Lead Clinical Research Associate

Job Title: Lead Clinical Research Associate

Job Description

The Lead Clinical Research Associate (LCRA) performs site management and re-monitoring activities for assigned legacy studies to ensure that previous monitoring work complies with the study-specific Monitoring Plan, protocol, standard operating procedures, ICH GCP, and applicable regulatory requirements. This role provides leadership, subject matter expertise, and operational support to investigative sites and study teams, particularly for re-monitoring activities where previous site staff or study team members may no longer be available. The LCRA evaluates prior CRA activities, reviews monitoring visit reports, identifies quality and compliance risks, supports remediation and CAPA activities, and communicates key issues and trends to the Clinical Trial Manager and broader management team.

Responsibilities

• Perform site management and re-monitoring activities for assigned legacy clinical studies to ensure compliance with protocols, monitoring plans, SOPs, and regulatory requirements.
• Review previous monitoring activities, including monitoring visit reports, protocol deviations, and site-level compliance, to assess the adequacy and quality of prior oversight.
• Conduct detailed source data review and verification as appropriate, including chart review, to confirm data accuracy, completeness, and alignment with source documentation.
• Review informed consent documentation to ensure proper consent processes, version control, and adherence to regulatory and ethical requirements.
• Perform comprehensive TMF/eTMF, ISF, and essential document reviews, including regulatory binder review and reconciliation, to support inspection readiness.
• Identify quality, compliance, and inspection-readiness risks at both site and study levels, and document findings in a clear and structured manner.
• Support remediation activities by providing evidence-based recommendations and working with study teams and sites to address identified issues.
• Conduct on-site and remote re-monitoring visits, providing ongoing site support and guidance on corrective and preventive actions.
• Track findings, deviations, and issues arising from re-monitoring activities and support the implementation and follow-up of CAPA plans.
• Escalate significant issues, risks, and trends to the study team, Clinical Trial Manager, and management as appropriate, ensuring timely communication and resolution.
• Maintain study trackers, logs, and documentation to support project oversight, audit trails, and regulatory inspection readiness.
• Apply senior monitoring and oversight expertise across site management, re-monitoring, CAPA support, TMF/ISF reconciliation, and risk management activities.
• Contribute to legacy-study remediation initiatives by ensuring that historical data, documentation, and processes meet current quality and compliance expectations.
• Travel regionally within the USA, as required (up to approximately 70%), to perform on-site visits and provide direct site support.

Essential Skills

• Previous experience reviewing monitoring visit reports, with the ability to assess the quality and adequacy of prior monitoring activities.
• Proven ability to provide clear, evidence-based remediation recommendations based on review of historical monitoring activities and documentation.
• Strong capability to identify quality and compliance risks and to recommend and support appropriate remediation and CAPA activities.
• Advanced TMF/eTMF and ISF inspection-readiness expertise, including regulatory binder review and reconciliation.
• Proficiency with Microsoft Office applications, including Excel, and experience with CTMS and clinical trial systems.
• Ability and willingness to travel regionally within the USA up to approximately 70%.
• Minimum 7 years of clinical research experience, including at least 5 years of hands-on on-site monitoring experience.
• Minimum 2 years of monitoring oversight experience, including on-site oversight visits.
• Hands-on experience conducting site qualification visits (SQV), site initiation visits (SIV), interim monitoring visits (IMV), and close-out visits (COV).
• Advanced TMF/eTMF inspection readiness and CAPA management experience.
• Neurology clinical trial experience and Phase 13 clinical trial experience.
• Strong knowledge of ICH GCP, applicable regulations, and ICH E6(R3).

Additional Skills & Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field.
• Legacy study re-monitoring experience (preferred).
• PET or MRI trial experience (strongly preferred).
• Experience with chart review in a clinical research context.
• Demonstrated ability to provide leadership and subject matter expertise to sites and study teams.
• Experience supporting risk management and inspection-readiness activities across multiple studies.

Work Environment

This is a remote-based position with substantial regional travel within the USA, up to approximately 70%, to conduct on-site re-monitoring and oversight visits. The role involves working extensively with electronic clinical trial systems, including CTMS, TMF/eTMF platforms, ISF documentation, and standard productivity tools such as Microsoft Office and Excel. The environment is highly regulated and quality-focused, emphasizing inspection readiness, detailed documentation, and adherence to ICH GCP and applicable regulations. Work is performed collaboratively with cross-functional study teams and investigative sites, combining remote document review and communication with frequent in-person site interactions.

Job Type & Location

This is a Contract position based out of North Billerica, MA.

Pay and Benefits

The pay range for this position is $85.00 - $90.00/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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 9, 2026.

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.