Sr. CTM Associate

职位描述

Job Responsibilities:

• Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas. With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.

• 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.

• Participates 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.

• 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.

Basic Requirements:

• 4+ years of experience and a BS or BA in a relevant scientific discipline.

OR

• 4+ years of experience and an RN (2 or 3 year certificate).

• CCRA or other certification desired