Lead Clinical Research Associate

12 month renewable contract1099 ONLYMust have Lead CRA or Oversight CRA experienceJob Title: Lead Clinical Research AssociateThis contract Lead Clinical Research Associate role focuses on overseeing clinical operations site management and monitoring activities for multiple trials as a 1099 contractor. You manage the development, coordination, and implementation of trial-specific processes and systems, while providing daily leadership and guidance to a team of clinical research associates. You serve as a key member of the site management trial team, collaborating closely with project leadership and cross-functional partners to ensure high-quality execution of clinical trials in accordance with regulatory and organizational standards.ResponsibilitiesManage site management and clinical monitoring activities in accordance with contractual agreements, departmental guidelines, standard operating procedures, applicable international, federal and state regulations, and ICH guidelines.Lead the execution of all monitoring services according to project-specific scopes of work, ensuring quality, timeliness, and regulatory compliance.Provide leadership and functional oversight for monitoring teams, including Clinical Research Associates I, II, III, and senior staff, across all phases of clinical trials from start-up through enrollment, closeout, and archiving.Participate in the development of study protocols, protocol revisions and amendments, monitoring plans, scopes of work, and operations manuals with appropriate guidance from project leadership.Oversee and coordinate site start-up activities, including site selection, initiation, and activation, ensuring that all trial sites are prepared to conduct the study in compliance with study requirements.Review and interpret clinical monitoring plans, timelines, milestones, and deliverables, and ensure that monitoring activities align with project goals and client expectations.Lead risk-based monitoring activities and remote data surveillance to proactively identify, assess, and mitigate site and study risks.Review monitoring visit reports (trip reports) and associated documentation to ensure completeness, accuracy, and consistency with regulatory and organizational standards.Collaborate with clinical operations administration to identify training needs and performance concerns for monitoring team members, and provide ongoing input into individual training and development plans.Encourage and support team members in attending appropriate training sessions and meetings to maintain and enhance their professional competencies.Monitor team adherence to sponsor-specific administrative policies and procedures, providing guidance and corrective direction as needed.Support budget development and contribute to financial planning for assigned projects with minimal guidance, ensuring that monitoring and site management activities remain within scope.Serve as a key point of contact for internal and external partners, including project leaders, principal investigators, and other functional group representatives, to ensure effective communication and collaboration.Work extensively with clients to align expectations, communicate progress, and address issues related to site management and monitoring.Maintain awareness of team performance, workload, and training needs, and escalate issues appropriately to senior clinical trials leadership.Demonstrate strong ownership and accountability for assigned projects, proactively anticipating issues and acting quickly to resolve them.Support the broader departmental mission, goals, and organizational initiatives by contributing to process improvements and collaborative efforts.Travel to clinical trial sites and meetings as needed, providing on-site leadership, oversight, and support for monitoring activities.Essential SkillsAt least 7 years of experience in clinical research with significant involvement in study start-up, clinical monitoring plans, and leading monitoring teams.Proven experience as a Lead Clinical Research Associate, with the ability to step into a lead role immediately rather than transitioning from a non-lead CRA position.Extensive experience in site monitoring and/or project or program management, with demonstrated capability to oversee approximately 25–50 clinical trial sites.Strong background in mentoring and guiding Clinical Research Associates, including reviewing trip reports, monitoring timelines, and tracking project milestones.Hands-on experience with risk-based monitoring strategies and remote data surveillance to ensure data quality and site compliance.Proficiency with electronic data capture systems and associated clinical trial documentation processes.Solid understanding of regulatory guidelines, including ICH and applicable international, federal, and state regulations governing clinical research.Demonstrated ability to work extensively with clients, manage expectations, and maintain professional relationships in a high-visibility environment.Willingness and ability to travel as needed, with a minimum expectation of approximately 25% travel, without limitations on location.Residence within approximately 30 minutes of a major airport to support frequent and flexible travel requirements.Varied therapeutic area experience, such as Cardiology, Gastrointestinal, Infectious Disease, Neuroscience, Oncology, or similar fields.Strong communication skills, with the ability to communicate clearly and succinctly in both written and verbal formats.Confident, proactive, and self-directed work style, with the ability to anticipate issues and act quickly.Demonstrated willingness to go the extra mile to support team objectives and project success.Comfort working in a fast-paced, high-visibility environment where priorities and needs may shift quickly.Additional Skills & QualificationsPrior experience leading monitoring teams within large or complex clinical research organizations.Experience contributing to the development of protocols, monitoring plans, scopes of work, and operations manuals.Exposure to multiple therapeutic areas, providing breadth of insight across diverse clinical indications.Experience in budget development or financial planning for clinical operations activities.History of participating in or leading training initiatives for CRAs and monitoring staff.Demonstrated ability to collaborate effectively with project leaders, principal investigators, and cross-functional teams.Strong organizational and time management skills, with the ability to manage multiple sites and priorities concurrently.Comfort with remote work tools and virtual collaboration platforms for coordinating dispersed teams.Work EnvironmentThis role operates as a 1099 contractor and is structured as a 100% remote position, offering flexibility in work location while requiring reliable connectivity and a professional home office setup. The work environment is fast-paced and high-visibility, with frequent interaction with internal stakeholders, external partners, and clients. You collaborate virtually with a mission-driven, highly collaborative clinical research team that values transparency, inclusion, and shared success. The position involves regular use of electronic data capture systems, remote data surveillance tools, and other clinical trial technologies to manage monitoring and site activities. Although the role is remote, you must be prepared to travel at least 25% of the time for site visits and meetings, and you should live within approximately 30 minutes of a major airport to facilitate travel. The culture emphasizes meaningful work, professional growth through exposure to diverse therapeutic areas and training resources, and a supportive environment that encourages initiative, ownership, and continuous learning. Dress expectations align with professional standards appropriate for remote meetings and on-site visits, adapting to site-specific requirements when traveling.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.RequirementsEligibility 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 TypeThis is a fully remote position.Application DeadlineThis position is anticipated to close on May 29, 2026.About ActalentActalent 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 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.