Clinical Trials Management Associate

Job Title: Clinical Trials Management Associate - III*

Location: Santa Monica, CA

Duration: 12 Months

Specific 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

• 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

• 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.

Specific Education & Experience Requirements:

• 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