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Typically serves as the Lead CRA (LCRA) with full responsibilities for clinical monitoring and line management of Clinical Research Associates (CRAs). Ensures appropriate communication, regulatory documentation, and ongoing oversight. Provides support for business development.
Communication - Keeps project leadership apprised of team issues, seeking guidance as needed. 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. Typically acts as LCRA on studies.
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 Institutional 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.
Administrative - Provides status reports to the PM and the Sponsor on-site initiation, enrollment, visit(s) scheduled, and trip report completion.
Line Manager – May be responsible for the supervision and administrative oversight of direct reports, which are most commonly CRAs. Develops training plan and assures training compliance for all direct reports. Evaluates strengths/developmental opportunities of staff members. Sets clear goals and objectives for all direct reports. Completes performance reviews and implements performance plans. Ensures CRA 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. Provides feedback to management on areas for process improvements and may participate 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. 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), e-mail, 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 strongly preferred.
Internal Number: 18001022
About Syneos Health
Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.