Senior Clinical Research Associate

Description

• One of our clients is seeking a highly experienced Senior CRA with in-depth knowledge of Phase I through III Clinical Trials.
• The candidate will work closely with the Clinical Program Manager, be responsible for the planning, implementation, monitoring and site management of clinical studies.
• The candidate must have in-depth experience in conducting pre-study, site-initiation, monitoring, and closeout visits.
• The candidate may be responsible for training of CRAs/CRO in conduct of such visits.
• Responsibilities may include managing clinical supplies, working with/managing CROs, recruiting investigators, organizing investigator meetings, setting up internal central systems as needed, assist in writing study protocols, final study reports, SOPs, expedited/annual safety reports, and designing and implementing CRF's.
• Duties also include liaison activities with manufacturing and multiple project group members.

• Requires a BS, RN, or RPh and 5+ years of related clinical experience.
• Requires knowledge of FDA, ICH and GCP guidelines.
• This is a very hands-on position in a very small start-up clinical group.
• Ability to work independently, excellent interpersonal and communication skills are critical, as is flexibility and strong attention to detail.
• Ability to travel when required