Sr. Clinical Research Assocaite

Position Purpose

Independently manage multiple Phase 3 international trials; select and manage CRO and vendor teams; contribute to protocol development, study planning; oversee and track study budgets. Report to Manager, Clinical Operations (or higher).

Responsibilities
* Contribute to CRO and vendor identification and selection process;
* Contribute to management of CROs and other study partners (monitoring, data management, labs) for assigned trials;
* Contribute to development and management of vendor and investigator budget and payment process;
* Oversee study activities (investigator recruitment, start-up, enrollment, monitoring, data collection, reporting);
* Prepare study progress updates;
* Develop study documents including protocols, amendments, CRFs, ICFs, and other study documents;
* Organize and develop materials for investigator, expert, and other meetings;
* Contribute to clinical SOP development; and
* Travel an estimated 50% of the time (or as needed).

Qualifications
* BS in Life Sciences/RN or a related discipline or equivalent with minimum of 5 years industry experience in clinical trial execution and management (e.g. monitoring, data management, regulatory, contracts, and technical writing);
* Familiarity with international trials and Phase I-III desirable;
* Solid knowledge of GCPs and ICH guidelines;
* Experience working with CROs;
* Experience in study budget development a plus;
* Computer proficiency;
* Excellent written and verbal communication skills; and

Energetic, positive, flexible, team-oriented, and interested in professional growth

To find out more about Real Staffing please visit www.realstaffing.com