Psicro
Lead Clinical Research Associate
Remote, US, United States
Sponsorship not specifiedDetected 44 days ago
Project ManagementClinical TrialsClinical ResearchCRISPRResearchLeadershipCommunicationCollaborationProblem SolvingMentoringPublic SpeakingMicrosoft Office
About the role
- We focus on delivering quality and on-time services across a variety of therapeutic indications.
- You will ensure high-quality execution, compliance, and timely delivery.
- You will act as a key point of coordination across cross-functional teams.
Responsibilities
- 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.
- Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region 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.
- Performs clinical supplies management with vendors on a country and regional level.
- Manages the project team in site contracting and payments.
- Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
Requirements
- 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.
Nice to have
- Strong experience in Oncology preferred.
Benefits
- Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
Visa & Work Authorization
- For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future
This listing is sourced directly from Psicro's careers page and normalized into a canonical job model.