Lead Clinical Research Associate
PSI CRO AG
Lead Clinical Research Associate
PSI CRO AG
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- 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
Requirements
- 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 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 communication, collaboration, and problem-solving skills
- Ability to travel up to 50% (depending on project needs)
- Valid driver’s license (if applicable)
- For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future
Benefits
- Employees can work remotely
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
site monitoringclinical project managementdata integrity evaluationCAPA developmentsource data verificationstudy audit preparationpatient enrollmentclinical supplies managementprotocol deviation reportingmonitoring visit types
Soft skills
communicationcollaborationproblem-solvingplanningmultitaskingmentoringleadershiptrainingreportingteamwork
Certifications
MDMPharmRNdegree in Life Sciences
