Clinical Trials Management Associate – III

Job Description

Duties and Responsibilities:

• Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines.
• Assists in CRO or vendor selection.
• With guidance from supervisor coordinates CROs or vendors.
• Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
• Participate or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams (May participate in abstract presentations, oral presentations and manuscript development).
• Interfaces with individuals in other functional areas to address routine study issues.
• May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants
• Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
• Travel is required.

Education, Experience & Certifications/ License:

• 4+ years of experience and a BS or BA in a relevant scientific discipline.
• 4+ years of experience and an RN (2 or 3 year certificate).
• CCRA or other certification desired.

Knowledge, Skills and Abilities:

• Excellent verbal, written, interpersonal and presentation skills are required.
• Working knowledge and experience with Word, PowerPoint and Excel.
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
• Must have a general understanding of functional issues and routine project goals from an organizational perspective.