Lead Clinical Research Associate

- Coordinates investigator/ site feasibility and identification process, as well as study startup.

- Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.

- Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.

- 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.

- Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.

- Coordinates planning of supervised monitoring visits and conducts the visits.

- Manages the project team in site contracting and payments.

- Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.

- 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.

- Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.

- Delivers trainings and presentations at Investigator Meetings.

- Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.

- 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 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.

- Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.

- Conducts project-specific training of site Investigators.

- 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.

- Must have prior experience monitoring or managing sites and CRAs with knowledge of US and Canadian regulatory guidelines and practices.

- Experience with all types of monitoring visits in Phases I-III.

- Strong experience in Oncology preferred.

- Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, 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 Communicatio