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 i n 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

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.

Skill:

• 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 judgement to address potential problems, elevating concerns to the next level of management when necessary. Understands clinical monitoring process and understands the role of clinical research associates in pharmaceutical drug development. Knowledgeable about relevant GCP and FDA regulations as they relate to clinical trial compliance.
• Some project travel is required.
• Must be highly customer service oriented and have creative initiative with a positive attitude.
• Understands and shares the organizational values of developing and maintaining good relationships internally and externally. Quality of interactions reflects emphasis on relationships.
• Strong communication (both written and verbal), personable, able to develop a positive rapport with clinical sites.
• Applies good judgment to address potential problems, elevating concerns to the next level of management when necessary.
• Strong attention to detail.
• Strong computer and organizational skills.
• Proficiency in some software system(s) as appropriate for needs of department required.

Physical Requirements:

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. The noise level in the work environment is low.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.