Santa Monica, CA
Contract Duration: 5-18 months
Rate: Negotiable
Responsibilities:
- Excellent employment opportunity for a Clinical Trials Management Associate II in the Santa Monica, CA area. (onsite)
- 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.
Experience:
- 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.