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Lead CRA

Aerotek

01/13/2021

Posting ID: JP-001980020

Full Time
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Description:

• Provide leadership for the project team responsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work:

• Define, assign, coordinate, oversee and assess utilization and productivity of team members’ daily in-house activities according to trial-specific scope of work, budget, and timelines.

• Define, assign, coordinate, oversee and assess utilization and productivity of sub-contractors including independent contract CRAs, vendor or sponsor-provided CRAs, and other contracted services.

• Provide site management and clinical monitoring expertise, and leadership to assigned team. Provide advice and guidance to team members for assessment, resolution, and documentation of site and project issues.

• Identify resource needs and supervise team members’ work assignments, utilization and productivity.

• Direct and prioritize team efforts and assess overall team progress against project timelines and metrics. Develop performance standards for project team. Identify and notify project leader of emerging out of scope activities and study guidelines. Evaluate impact on resource needs, study processes and related documents.

• Review and approve team deliverables focusing on quality and timeliness of all activities within the defined scope of work.

• Manage the development and maintenance of clinical trials documents, processes, and systems according to trial-specific scope of work and budget with minimal guidance. Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance.

• Coordinate the development, use and maintenance of study- specific processes, related documents, templates and other site management, communication, monitoring and regulatory tools.

• Define site selection and activation guidelines and related activities with the project leader, the principal investigator, and the sponsor. Approve sites in collaboration with the project leader and the sponsor.

• Train and supervise the team on trial-specific collection, review and approval of clinical trial documents and associated processes. Provide final approval of essential clinical trial documents.

• Observe for consistency in the conduct of the study and data collection according to the protocol and study objectives. Oversee identification of study and site issues and assist with resolution and documentation.

• Provide management of the development, implementation and maintenance of the clinical trial management system, related tracking tools and status reports.

• Apply best practices to site management clinical trials processes.

• Serve as key site management trial-team member to internal and external partners and to the project core team (project leader, principal investigator and other functional group key representatives).

• Collaborate with internal and external partners to develop trial specific tools and processes, with guidance, for efficient management of tracking site and study status, enrollment, data collection, query resolution, and other trial activities.

• Provide input regarding the development of the CRF (data capture forms) design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports.

• Facilitate communication between designated internal and external contacts (including contracts, clinical supplies, pharmacy, and sponsor) and study sites. Facilitate cross-functional team communication and proactive problem solving regarding study progress and trial issues with guidance.

• Manage production, review and approval of trial-related reports, including site status reports, site payments, regulatory status reports, trip reports, and expense reports for internal and external dissemination. Review reports for identification and resolution of study and site issues. Notify appropriate team members of findings and action plan.

• Organize, lead, and participate in study teleconferences and meetings with the trial team and other study partners.

• Coordinate and oversee trial-specific training for project team members which may include therapeutic in-service, reference materials, investigator meeting, and team training, Provide and document regular feedback to individual team members. Maintain documentation, providing specific examples of performance issues.

• Recognize accomplishments of individual team members and the team as a whole.

• Manage all aspects of performance management including compiling and providing feedback to the team members’ annual performance evaluations, identifying strengths and areas for improvement using specific examples, and providing input for Individual Development Plans. Assist with development and delivery of performance reviews and work improvement plans.

• Attend appropriate leadership meetings, department meetings and organizational meetings. Encourage team members to attend appropriate team, department and educational meetings.

• Assist in the development, implementation and revision of processes, SOPs and standard forms.

• Support the mission, department goals and organizational activities.

• Oversee team dynamics to foster professional relationships.

• Maintain awareness of developments in clinical research regulations and therapeutic areas by reading related literature, attendance at professional meetings and research seminars.

• Encourage and support cross-functional and therapeutic information exchange.

• Participate in special assignments as requested by project leader.

• Interview job candidates and make hire recommendations for teams.

• Complete administrative activities accurately and in a timely manner, e.g., time tracking, attendance reports, training file.

• Encourage team to seek opportunities for personal development.

• Receive and review audit findings, develop action plan for audit response and provide input for formal audit response with guidance.

• Perform other related duties incidental to the work described herein.

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Claudia Dallas

Email: cdallas@aerotek.com

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