Lead Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Assume a leadership position within the study team, providing oversight and direction to the clinical team while steering trial activities at a country or regional level.

• Ensure the execution of high-quality standards, compliance, and timely delivery of projects.

• Serve as a pivotal coordination point across various cross-functional teams.

• Emphasize leadership, mentorship, oversight, and uniformity in monitoring practices over direct site management, with minimal to no site assignments and a low-travel model.

• Monitor project timelines, patient enrollment, data cleaning, and compliance, while implementing necessary corrective and preventive actions.

• Evaluate monitoring visit reports for all visit types and guarantee compliance in reporting from the Monitors within the region.

• Function as the primary communication link between Monitor, Site Management Associate, Regional Project Lead, and/or Project Manager.

• Facilitate project team calls at the country level and provide status updates and reports to the Regional Lead/Project Manager.

• Deliver project-specific training and develop training materials for the project team under the guidance of a Project Manager and Regional Project Lead.

• Oversee source data verification and address data queries at the site level within the country/region; assess and manage study risks at the site level.

• Ensure appropriate handling, usage, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies at the country/region level.

• Review essential study documents and supervise the reconciliation of study Investigator Site File (ISF)/TMF at both site and country/region levels.

• Guarantee data integrity and compliance at the site level.

• Collaborate with investigators/site feasibility and identification processes, as well as facilitate study startup.

• Manage Monitors in the query resolution process, including Central Monitoring observations.

• Coordinate the flow of safety information and reporting of protocol/process deviations.

• Oversee clinical supplies management with vendors at the country and regional levels.

• Ensure that study-specific and corporate tracking systems are updated promptly.

• Plan and coordinate supervised monitoring visits and execute the visits.

• Manage the project team in site contracting and payments.

• Conduct ongoing evaluations of data integrity and compliance at the country/regional level.

• Conduct site audit preparation visits, may participate in site audits, and facilitate resolution of site audit findings at the country/regional level.

• Guide the project team in the development and implementation of CAPA.

• Coordinate the project team in reviewing, managing, and reporting process deviations.

• Conduct initial training and authorization monitoring visits for Monitors and act as a mentor for newly promoted Lead CRAs.

• Provide training and presentations at Investigator Meetings.

• Ensure proper definition, communication, documentation, and fulfillment of subject recruitment targets and project timelines at the site level.

• Ensure accurate and timely communication with trial sites regarding Adverse Events and protocol/process deviations.

• Supervise Site Management Associates in managing the flow of documents and laboratory supplies between the site and the Central/Regional Lab/Central Reviewer.

• Assist in preparing draft regulatory and ethics committee submission packages.

⛳️ Requirements

• Relevant educational qualifications, such as MD, MPharm, RN, or a College/University degree in Life Sciences, or an equivalent combination of education, training, and experience.

• Minimum of 4 years of site monitoring experience with involvement in global clinical projects as a Lead Monitor or an equivalent qualification level.

• Experience with all types of monitoring visits in Phase II and/or III.

• Strong experience in Oncology is preferred.

• Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other forms of Cell Therapy, Gene Therapy, or Nuclear Medicine is preferred.

• Strong experience in Gastrointestinal conditions (Crohn's, Ulcerative Colitis, IBS) is preferred.

• Full proficiency in English.

• Proficiency in MS Office applications.

• Ability to plan, multitask, and work effectively in a dynamic team environment.

• Excellent communication, collaboration, and problem-solving skills.

• Willingness to travel.

• Valid driver’s license (if applicable).

🏝️ Benefits

• Employees have the option to work remotely.