Note: The job is a remote job and is open to candidates in USA. PSI CRO is a leading Contract Research Organization with over 25 years in the industry, focusing on delivering quality and timely services across various therapeutic indications. The Lead Clinical Research Associate will oversee and guide the clinical team while ensuring high-quality execution and compliance in clinical trials at a country or regional level.
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
Skills
- 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
- 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)
- 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
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