Lead Clinical Research Associate (Home-Based)

Job Title: Lead Clinical Research Associate (Homebased)Job DescriptionWe are seeking a dedicated Lead Clinical Research Associate to step into a dynamic and fast-paced study environment. This role requires someone who can quickly learn, bring structure, and remain flexible. The position is more administratively focused than typical Lead CRA roles, involving significant spreadsheet management, tracking, and reporting. As the study progresses, the workload may normalize, but initially, it will be challenging and demanding, suited for someone comfortable navigating complex details.Responsibilities

• Coordinate and lead site monitoring assignments, ensuring timely scheduling of site visits according to the monitoring plan.
• Define and approve site selection and activation guidelines in collaboration with the project leader and sponsor.
• Develop and maintain study-specific processes, documents, and monitoring tools.
• Utilize available tools to identify and act upon risk indicators to support risk-based monitoring strategies.
• Oversee and assess team productivity, providing leadership and guidance for resolving site and project issues.
• Manage resources, prioritize team efforts, and assess team progress against project timelines and metrics.
• Maintain data integrity and quality documentation, ensuring study setup within CTMS.
• Implement and oversee risk-based monitoring strategies to identify and resolve quality concerns.
• Review and approve team deliverables, focusing on quality and timeliness.
• Develop and maintain clinical trial documents and systems according to the trial scope of work and budget.
• Collaborate with internal and external partners to develop trial-specific tools and processes.
• Facilitate communication between internal and external contacts and study sites.
• Organize and lead study meetings and teleconferences.
• Manage production and approval of trial-related reports and oversee on-site monitoring visits.
• Assist in the development and revision of processes, SOPs, and standard forms.
• Provide expert guidance on site regulatory matters and develop corrective action plans for compliance issues.
• Contribute to department initiatives and process improvements.

Essential Skills

• 7+ years of experience in study start-up, clinical monitoring plans, and team leadership.
• 4+ years of experience as a Lead Level CRA, Clinical Team Lead, or Clinical Operations Lead.
• Multiple site monitoring experience or extensive project/program management experience.
• Willingness to travel as needed, minimum 25%, living within ~30 minutes of a major airport.
• Therapeutic area experience in Cardiology, Cardiovascular, Diabetes, Obesity, Endocrinology, and COPD.

Additional Skills & Qualifications

• Proactive and self-directed with strong ownership skills.
• Ability to anticipate issues and act quickly, communicating clearly and succinctly.
• Comfortable in a fast-paced, high-visibility environment.
• Leadership and strategic oversight in clinical trial operations.
• Experience creating and operationalizing monitoring plans and balancing study budgets against timelines.

Work EnvironmentThis position is 100% remote, offering flexibility and a collaborative culture. You will be part of a mission-driven team advancing groundbreaking clinical research, with opportunities for hybrid work arrangements to support work-life balance. Job Type & LocationThis is a Contract position based out of Durham, NC. Pay and BenefitsThe pay range for this position is $85.00 - $95.00/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 Durham, NC. Application DeadlineThis position is anticipated to close on Nov 23, 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.

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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.

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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.

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