The Clinical Team Lead is a position of responsibility within a project with the requirement to supervise one or more Clinical Research Associates (CRAs). As a high-profile role within the project, the CTL must be able to interact confidently with the client, maintaining a professional image when working under time constraints and act responsibly as a representative of MedSource.
A CTL is expected to use their experience as a “Subject Matter Expert” for the CRAs and to help the CRAs on their project to develop skills to improve their project specific performance. They may be called upon to interact independently with Sponsors not directly related to current assigned projects in a bid defense or to assist in training less experienced CRAs. The CTL role provides functional leadership to a defined group of CRAs working on a designated project to ensure satisfactory performance and completion of the project.
DUTIES AND RESPONSIBILITIES:
- Act as primary contact for CRA team allocated to the project.
- Establish ongoing project priorities with the Project Manager (PM) and Sponsor.
- Create CRA monitoring tools to assist the CRAs with SDV, regulatory document tracking, site visit planning, and timely site contacts.
- Assist the PM with the preparation of a project Kick Off Meeting and /or Investigator Meeting.
- Conduct or help with the conduct of ongoing project team meetings or teleconferences in order to monitor study progress and address any issues raised by the project team.
- Understand the product, protocol and therapeutic area in sufficient detail to be able to advise and discuss with CRA team and study site personnel.
- To provide support and guidance to the CRAs when dealing with site, lab, and regulatory document deficiencies.
- Track key project deliverables as agreed with the PM.
- Identify and escalate time utilization trends to the PM which could lead to a “change in scope” in the budget or which could lead to project plan revisions.
- Assist with the creation of project plans and project specific documents and templates.
- Review monitoring visit reports to ensure quality, completeness and compliance with ICH GCP E6(R2), relevant SOPs, relevant procedures, monitoring plan and Sponsor expectations.
- Participate in TMF QC reviews per study specific requirements and assist CRA Line Managers with CRA compliance with established TMF SOPs.
- Conduct site visits or accompany CRAs on site visits as needed for training, remediation, performance assessment or performance evaluation visits.
- Serve as a proactive member of the project team liaising closely with the PM on all clinical monitoring related issues.
- Remain up to date and in compliance with all relevant SOPs and regulatory requirements.
- Ensure that all clinical team members are maintaining appropriate clinical documentation according to ICH, GCP E6(R2), relevant SOPs, Clinical Monitoring Plan, Communication Plan and other relevant regulatory and project specific guidance documents.
- Ensure adequate communication with the monitoring team including contract staff and with other departments as appropriate to maintain effective and productive relationships.
- Work with relevant managers to address any problems promptly.
MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
- BA/BS degree in a life science field, or equivalent education and experience.
- At least four (4) years of clinical research industry experience.
- Diverse therapeutic area expertise and skills.
- Experience as a Senior CRA on multicenter trials and also demonstrate professional maturity, leadership ability and strong problem-solving skills.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Proven experience in clinical research and able to work independently with minimal supervision.
- Excellent oral and written communication skills.
- Excellent interpersonal and organizational skills with strong attention to detail.
- Good customer/client relationship management and proactive problem-solving skills.
- Knowledge of the principles, methods, and procedures of clinical research.
- Ability to guide, mentor and supervise less experience staff.
CONDITIONS OF EMPLOYMENT:
- Verification of educational requirements, employment history, professional references, and certifications/training.
WORKING CONDITIONS AND PHYSICAL EFFORT:
- Position can be either office-based or home-based, but work will be required away from MedSource offices, at Sponsor offices, and may require national or international travel.
- May also involve travel to meetings or attendance at conferences. Overnight stays may be required. Additionally, weekend and evening session may be required depending upon the workload and nature of current programs.
- Lifting less than 50 pounds.
- Sitting for long durations.
- Up to 50% Travel Required.
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