Sr. CRA

POSITION: Senior Clinical Research Associate/ Clinical Trial Manager

DESCRIPTION

Participates in the planning and is accountable for the conduct of clinical studies, with a strong focus on enrollment, quality of data, site relationships, and oversight of challenging and/or complex studies.

RESPONSIBILITIES

• Regularly represents department in team meetings, leads teams and drive collaborative efforts (e.g., protocol development, CRO selection, etc.).
• Oversees and is accountable for feasibility assessments for new studies.
• Responsible for TMF contents and accountable for TMF reconciliation.
• Oversees and is accountable for the content of study documents (i.e., consents, study instructions, etc.).
• Oversees and is accountable for the content of study workshops and investigator meeting materials and presents at study training workshops and investigator meetings.
• Oversees and is accountable for the development and management of study start-up, maintenance, and close-out activities, including the development of the monitoring plan.
• Oversees and is accountable for the adherence to timelines, study quality, budget for assigned studies and participates in timeline development.
• Oversees and is accountable for the preparation of training materials and training of internal and external staff involved in the study team.
• Oversees and is accountable for the vendor identification and evaluation process including RFP development.
• Responsible for the assessment and management of vendor performance and in collaboration, develops and manages performance metrics.
• Oversees and is accountable for the consistency and quality of content of clinical protocols and amendments and leads the protocol development process.
• Assists in and is accountable for the development and completion of individual site recruitment and back-up plans and is responsible for the development of risk mitigation and contingency plans to keep trial enrollment on target.
• Accountable for the oversight of all monitoring of clinical sites, may include complex or challenging studies and sites.
• Oversees and is accountable for the identification and qualification of clinical investigators and assists in the selection of investigators.
• Oversees and is accountable for the development of investigator site budgets, manages routine site budget negotiations and assists with more complex site budget negotiations.
• Oversees and is accountable for the development of the Vendor evaluation and selection process and development of Vendor budget.
• Responsible for drafting Central Ethics Committee applications for studies conducted outside of the United States

EXPERIENCE

• 4-6 years industry experience, including a minimum 4 years clinical research experience.
• Experience in line management and/or mentoring of CR Assistants and CRAs
• Contributes in process improvement teams
• Understanding of the clinical development plan and how the individual projects are impacted
• Demonstrates understanding of CRO and other vendor roles
• Strong knowledge of the Code of Federal Regulations FDA guidance, CFR Title 21 and ICH GCPs.

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services.  Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .