Clinical Team Leader - CTL/ Sr CTL (Lead CRA and Line Manager)
Line manages Clinical Research Associates (CRAs) and may also serve as line manager for Clinical Team Leaders (CTLs). Provides guidance and coaching to clinical monitors as well as CTLs. Responsible for identifying best practices (geographically and therapeutically) within clinical monitoring and developing communications and training tools for the organization. Typically serves as Lead CRA (LCRA) on global projects and programs.
* Communication - Keeps project leadership apprised of team issues. Maintains timely and effective communication among team members and site staff. Attends Kick-Off, Quick Start, and Investigator meetings.
* Regulatory Documentation - Independently resolves protocol questions with the Project Manager (PM) and patient related issues with the Medical Monitor (MM). Maintains a record of all contacts with the PM or MM concerning protocol deviations and clarifications.
* Monitoring - Develops clinical plans and guidelines, including clinical monitoring plans. Assures compliance with monitoring intervals according to the project requirements. Responsible for identifying best practices (geographically and therapeutically) within clinical monitoring and developing communications and training tools for the organization. Typically acts as Lead CRA on studies that are often larger or more complex global projects and programs.
* Monitoring and Oversight - Reviews the study scope of work, budget, and protocol content. Provides training to project teams on protocol, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study. Leads weekly project calls with CRAs. Responsible for site assignments for CRAs. Ensures study specific training requirements are completed and documented. Provides assistance and/or co-monitoring with regional team for high enrolling or problematic sites. Collaborates with internal project team members to assure timely site initiation process. Facilitates the site selection process utilizing Quick Start methods and appropriate feasibility assessments, if applicable. Assists the PM with tracking site initiation status, including Institution Review Board (IRB) approvals and scheduling of site initiation visits to coincide with shipment of clinical supplies. Reviews site visit reports according to Company or Sponsor requirements. Reviews Clinical Trial Management System to provide oversight and to ensure timely entry of all operational aspects (required visits, duration, and frequency) according to contracted project scope. Requests clarifications and corrections to the visit reports, follow-up letters and other site correspondence. May serve as subject matter expert on implementing study specific factors into the trip report. Reviews system reports to track CRF collection/entry and quality. Assists with clinical listing reviews.
* Business Development - Prepares and presents materials for bid defense meetings. May support proposal development including creation of monitoring strategy.
* Administrative - Provides status reports to the PM and the Sponsor on-site initiation, enrollment, visit(s) scheduled, and trip report completion.
* Line Manager - Responsible for the supervision and administrative oversight of all direct reports, which are most commonly CRAs and could include less experienced CTLs. Develops training plan and assures training compliance for all direct reports. Develops training plan and assures training compliance for all direct reports. Evaluates strengths/developmental opportunities of staff members. Evaluates and advises on strengths/developmental opportunities of staff members. Sets clear goals and objectives for all direct reports. Completes performance reviews and implements performance plans. Ensures CRA and CTL metrics are met. Meets regularly with direct reports to mentor them and to evaluate workload and metric compliance. Provides data for the maintenance of resourcing tools. Collaborates with study leadership/management to identify project resourcing demands, resolving potential resourcing conflicts and facilitating mutually beneficial resolutions. Meets and provides feedback to management on areas for process improvements and participates in process improvement teams. Evaluates staff's competency to perform on-site visits independently via sign-off visits according to published requirements. Participates in interviewing, collaborates with HR/Training in assessing initial training needs, and orientates new hires into the team and function. Facilitates teamwork; influences and motivates team to accomplish goals by encouraging direct and open communication, resolving conflict, and demonstrating support to team members. Ensures required on-site CRA assessment, sign-off, and documentation occurs. Provides strong leadership to the team, encouraging engagement, innovation and open communication, while implementing Company procedures.
Performs other work related duties as assigned. Moderate travel may be required (up to 50%).
BA/BS degree in the science/health care field or nursing degree, or equivalent combined education and experience. Moderate independent field monitoring experience. Minimal lead monitoring or comparable supervisory experience. Effective supervisory experience. Demonstrates extensive understanding of SOPs, Work Instructions (WI), FDA, and local regulations as well as ICH GCP guidelines, and an advanced understanding and application of applicable therapeutic standards. Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Effective command of written and spoken local language, if not English, as well as English. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Must have valid, current driver's license and ability to secure corporate credit card. ACRP CCRA or equivalent certification/credentials are strongly preferred.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, 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. The Company, 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.