Clincial Research Associate

Santen Inc., an ophthalmic pharmaceutical company located in the beautiful Napa Valley has an immediate opening for an experienced Clinical Research Associate.  Santen offers a highly competitive compensation package including great benefits, a 401(k) retirement savings plan, and tuition reimbursement all with a company providing the growth and strength to build your future.

PRIMARY PURPOSE OF POSITION:

Incumbent plays an integral role in the development and implementation of clinical research projects.  Incumbent is expected to perform functions of significant scope with minimal supervision in the planning, implementation, execution, and analysis of human clinical studies in compliance with applicable governmental regulations and corporate procedures. Incumbent will act as a representative of Santen to the medical community, and therefore, must demonstrate a commitment to quality and integrity.

 

MAJOR DUTIES OF POSITION:

? Monitors Phase I-IV clinical trials and coordinates activities related to trial conduct with minimal supervision.

? Independently conducts on-site monitoring visits, and writes reports pertaining to monitoring activities.

? Verifies the complete, accurate, and consistent collection of study data, and ensures that studies are performed in compliance with the study protocol, GCPs, and Santen?s SOPs.

? Initiates regular contact with investigators and study site personnel to ensure timely study progress, protocol compliance, and to meet overall clinical objectives.

? Responsible for receiving and tracking adverse event reports from clinical studies to meet regulatory reporting requirements.

? Responsible for the preparation/procurement of essential clinical documents (i.e., Investigator?s Brochure, Protocols, Case Report Forms, Informed Consent Documents, financial agreements, IRB/EC approvals, etc.) and clinical supplies with minimum supervision.

? Assists in the preparation/writing of investigator brochures and protocols with moderate supervision.

? Assists in the evaluation and qualification of potential investigators for clinical trials.

? Assists in the negotiation of budgets with study sites.

? Assists in the evaluation of clinical data.

? May interact with CROs and other contractors.

? With minimal supervision, assists in the writing of INDs, IND Annual Reports, Clinical Study Reports, and NDAs.

? May be required to prepare written and oral presentations regarding clinical trial results.

? May serve as representative of Clinical Affairs on project teams.

? Suggests courses and seminars to attend to develop professional expertise in all facets of clinical research.

? Writes clinical standard operating procedures and provides training to entry level clinical research associates.

 

KNOWLEDGE AND SKILL REQUIREMENTS:

? A minimum of three years of clinical research experience, preferably in ophthalmology with a Bachelor?s degree in a scientific disciplines, RN, or BSN degree or equivalent.  A person with an advanced degree (MS, O.D. or Ph.D.) and less than three years clinical experience may be considered.

? Excellent written and verbal communication skills, and strong quantitative skills.

? Significant knowledge of FDA regulatory requirements.

? Significant knowledge of statistics and clinical trial design.

? High degree of computer proficient preferable in MS Office environment.

? Must exercise good judgment and operate with large degree of independence regarding routine and non-routine assignments.

? Must work well in a team environment.

 

PHYSICAL DEMANDS:

? Must be able to communicate effectively with internal client base (Regulatory, QA/QC, etc.) and clinical site personnel (physicians, coordinators, nurses, etc.).

? Must be able to travel as required.