Lead Clinical Research Associate

About the role

As a Lead Clinical Research Associate, you'll provide leadership, oversight, and mentorship across regional clinical trials while partnering closely with Project Managers, Regional Project Leads, CRAs, and cross-functional teams to ensure high-quality study execution. This role focuses on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model, emphasizing remote oversight and overall study quality.

Responsibilities

• Monitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/or Project Manager
• Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/Project Manager
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead
• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level
• Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF)/TMF at site level and country/region level
• Ensures data integrity and compliance at a site level
• Collaborates with investigator/site feasibility and identification process, as well as study startup
• Manages Monitors in the query resolution process, including Central Monitoring observations
• Coordinates safety information flow and protocol/process deviation reporting
• Performs clinical supplies management with vendors on a country and regional level
• Ensures study-specific and corporate tracking systems are updated in a timely manner
• Coordinates planning of supervised monitoring visits and conducts the visits
• Manages the project team in site contracting and payments
• Ensures ongoing evaluation of data integrity and compliance at a country/regional level
• Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level
• Oversees project team in CAPA development and implementation
• Coordinates project team in process deviations review, management and reporting
• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs
• Delivers trainings and presentations at Investigator Meetings
• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level
• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
• Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/Regional Lab/Central Reviewer
• Supports preparation of draft regulatory and ethics committee submission packages

Qualifications

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience
• Minimum of 4 years' site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level
• Experience with all types of monitoring visits in Phase II and/or III
• Strong experience in Oncology preferred
• Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, or Nuclear Medicine is preferred
• Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred
• Full working proficiency in English
• Proficiency in MS Office applications
• Ability to plan, multitask and work in a dynamic team environment
• Excellent Communication, collaboration, and problem-solving skills
• Ability to travel
• Valid driver's license (if applicable)

Benefits

• A stable, privately held CRO that has never undergone a merger or acquisition and has never experienced company-wide layoffs
• A unique leadership-focused CRA role with minimal travel and little to no routine site assignments
• Opportunities to mentor other CRAs and expand your leadership skills
• A collaborative, people-first culture where employees are genuinely supported
• Career development opportunities across a growing global organization
• The chance to contribute to innovative clinical research that improves patients' lives