Lead Clinical Research Associate

About this role

As a Lead Clinical Research Associate, you will hold a leadership role within the study team, overseeing and guiding the clinical team while driving trial activities at a country or regional level. You will ensure high-quality execution, compliance, and timely delivery. You will act as a key point of coordination across cross-functional teams.
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/ 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.

• 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 monitoring sites in the US.

• 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.

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.
PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Originally posted on Himalayas