Safety Committee Administrator

Overview

The Safety Committee Administrator provides moderate contracted project coordination and safety support on global and domestic programs, with an emphasis on Data and Safety Monitoring Boards (DSMB) and Endpoint Adjudication Committees (EAC).

What you'll do

• Represent the DSMB/EAC Coordination Team at global and domestic committee meetings (by teleconference and face-to-face), coordinating all logistical aspects and assisting with facilitation.
• Perform DSMB/EAC set-up, member contract execution and tracking.
• Administer member payment set-up, member honoraria management and oversight.
• Poll committee members and client contacts for meeting dates and times, and arrange meeting facilities as needed.
• Attend and complete meeting minutes for DSMB/CEC meetings as contracted.
• Provide oversight for all DSMB/CEC filing and assist the Safety Committee Specialist with dossier building and distribution.
• Obtain and track adjudication-specific documents for inclusion in the dossier, with working knowledge of the Event Adjudication System.
• Interface with internal and external parties to implement contracted DSMB/Adjudication services, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements, and review contractual documents for accuracy and coordinate approvals.
• Compile, create and submit follow-up to investigative sites.
• Coordinate and facilitate project meetings, draft meeting minutes, and post blinded and unblinded minutes and materials to client portals.
• Manage project-specific training and the set-up, maintenance and archival of program files, ensuring PV remains audit ready.
• Identify and redact subject identifiers per local requirements, retrain sites, and escalate reoccurrences to Data Privacy.
• Perform data entry into internal and external databases and tracking systems, and perform system reconciliations to identify issues that may affect project timelines.
• Oversee committee, travel and translation expenses, escalating as needed for timely member payment.
• Support specific activities performed by the specialty committee team.

What you'll need

• High school / secondary school diploma or equivalent, and relevant formal academic or vocational qualification.
• Technical positions may require a certificate.
• Previous experience providing the knowledge, skills and abilities to perform the job (comparable to at least 2 years), or an equivalency combining appropriate education, training and/or directly related experience.
• Strong problem-solving skills.
• Ability to work independently with minimal supervision, demonstrating initiative.
• Ability to build strong relationships.
• Ability to effectively analyze project-specific data and systems to ensure accuracy and efficiency.
• Ability to act as a liaison and communicate respectfully and diplomatically with clients, management, project team members and other internal staff.
• Self-motivated, positive attitude with effective oral and written communication and interpersonal skills.
• Excellent computer skills, including MS Office (Word, Excel, PowerPoint, Access).
• Ability to identify and set priorities and perform a variety of tasks simultaneously with strict deadlines.
• Strong attention to detail and accuracy, with orientation toward careful and meticulous work.
• Ability to maintain a positive and professional demeanor in challenging circumstances.
• Flexibility to reprioritize workload to meet changing project timelines.
• Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and company/Client SOPs and WPDs for all non-clinical and clinical aspects of project implementation, execution and closeout.

Details

• Location: Remote, North Carolina, USA.
• Work schedule: Standard (Mon-Fri).
• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations; potential occasional travel required.