Jobs and Careers

Clinical Lead

Remote (United States), United StatesRemotefull_timeVerifiedPosted 3 Jun 2024

💰 $115,000/yr($95,000/yr – $115,000/yr)

About the role

We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with.

Overview

Functions in a leadership capacity over the clinical function and monitoring team for a project. Has mastered the clinical monitoring process, associated competencies and understands the role of clinical research in drug development. Is an expert on relevant Good Clinical Practice (GCP), ICH, FDA regulatory requirements, and Standard Operating Procedures (SOPs). The Clinical Lead is responsible for quality and on time delivery of all tasks under the clinical function for each project assignment.

Responsibilities

Responsible for training and mentoring CRAs. Serves as the first point of contact for CRA questions, managing the FAQ and triaging questions to other team members as appropriate
Leads CRA meetings and communications and ensures proper site oversight and management by CRAs.
Oversees site assignments and ensures CRA team is adequately resourced
Responsible for timely Monitor Visit Report review per required review metrics, standards outlined in Monitoring Plan for each study; communicates report comments/issues to appropriate CRA for report edits. Reviews and confirms monitor time on-site, effectiveness, and efficiency.
Responsible for identifying suitable clinical trial sites
Ensures accuracy and completeness of feasibility questionnaires submitted by potential trial sites.
Review informed consent forms and site-level checklist templates for compliance and accuracy.
Ensures that issues and action items from monitoring visits are being addressed and closed in a sufficient manner and timeframe. If applicable, addresses with CRA need for site re-education
Serves as escalation point for critical or non-compliant issues identified during site visits, ensuring appropriate actions are taken.
Ensures issues and deviations are noted and tracked appropriately in reports and follow-up letters, also performing periodic trending activities
Communicates monitoring trends to Study Management (e.g., queries, protocol deviations) and site issues (e.g., enrollment barriers, etc.) which may require further attention
Performs Quality Control Visits or Interim Monitoring Visits at sites as needed
Support database build and UAT
Reviews data management reports to ensure timely query resolution and reviews data for trends as applicable
Assists in collection and assessment of clinical essential documents
Coordinate and oversee the site activation process
Develops source documents and study logs
Develops monitoring plans, annotated trip reports, and monitoring tools and templates
Attends study meetings and prepares weekly status reports for the Project Manager
Collaborates with the Project Manager and other functional leads on activities related to site monitoring, site management and clinical deliverables
May participate in Bid Defense Meetings
Contributes to content and presentation for kick-off meetings, both internal and external, pertaining to clinical management aspects.
Support database development and UAT

Requirements

Education:Required: a B.S./B.A. or equivalent years of work experience
Experience:A minimum of 5+ years of experience in the clinical research or pharmaceutical industry, or equivalent combination of education and experience. Experience in ophthalmology preferred.
Skills:

Must have mastered all core competencies of the Clinical Research Associate.
Exceptional organizational and management skills with the keen ability to prioritize multiple tasks with attention to detail.
Outstanding communication, both written and verbal skills, personable, able to develop a positive rapport with clinical sites and to lead and train, as needed other Clinical Research Associates.
Uses discretion and good judgeme