Regional Clinical Research Associate
MedFocus Pharmaceutical Research Opportunities (Seattle, Washington)

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Home-based Regional Clinical Research Associate needed in one of the following locations: Arizona, New Mexico, Oregon, Washington, or Utah.  (Ideally in cities with or near major airports)  Contract duration is 18 months to 2 years.

Contract Regional Clinical Research Associate is regionally based and responsible for the monitoring activities in compliance with FDA regulations, ICH/GCP guidelines and sanofi-aventis SOPs, to support US and Global Medical Affairs trials. This candidate will be part of the Oncology therapeutic area team. Primary functions of this position will include evaluating, initiating, monitoring and performing close-out visits for clinical investigative sites.  Successful candidate will monitor and manage all assigned clinical study sites to ensure subject safety and the timely delivery of project milestones.

*  Monitor multiple investigational sites within the oncology group in accordance with State and Federal Regulations, Good Clinical Practices and Standard Operating Procedures.

*  Work to ensure consistent implementation and successful completion of clinical research activities for assigned studies by conducting site initiation visits, routine monitoring visits, closeout visits and booster visits in accordance with the monitoring plan and sanofi-aventis SOPs.

*  Act as primary liaison between assigned sites and Regional Site Manager.

*  Communicate effectively with investigators and other research personnel, maintaining a professional demeanor.

*  Perform source document verification of CRFs according to SOPs and study specific requirements.

*  Ensure Case Report Forms (CRFs) are complete, legible and accurately reflect the source data.

*  Ensure appropriate reporting of adverse events by investigators according to GCP and SOPs.

*  Train on-site team, including the investigator and other site personnel, in proper conduct of clinical studies.

*  Monitor SAE reporting and request primary and follow-up information according to SOP.

*  Review protocol violations with the investigator and take corrective actions to ensure future compliance.

*  Responsible for the reconciliation of drug accountability records at sites.

*  Responsible for the reconciliation of all regulatory documents at sites.

*  Provide timely monitoring reports in accordance with SOPs.

*  Participate in clinical study team meetings.

*  Assist Data Management in the resolution of data queries.

*  Ensure availability of all study supplies at sites and participate in other tasks as needed.

Required Experience/Skills:

*  Minimum of two years experience monitoring clinical studies in the oncology therapeutic area.

*  Good understanding of the clinical development process, GCPs/ ICH/CFR regulations.

*  Knowledge of RECIST criteria; various oncology therapeutic area expertise, differing by study/tumor type.

*  Ability to utilize various electronic systems - intermediate computer skills required.

Professional Skills:

*  Ability to work independently.

*  Effective communication (verbal and written) and organizational skills.

*  Excellent interpersonal skills.

*  Excellent organizational and time management skills

*  Self-motivated, detail-oriented, and flexible

*  Commitment to teamwork.

*  Must have own laptop.

*  Ability and willingness to travel approximately 60% - 80%.

Education:

*  BA, BS in a relevant scientific discipline required.

*  CCRA Certified preferred