Patna-Bihar: Clinical Research Associate

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Date: 22-Jul-2008

Title: Clinical Research Associate II

This position is a Contract position for the duration of 1-2 years.

POSITION SUMMARY The Clinical Research Associate II works with multidisciplinary project teams in the development, start-up and completion of clinical research studies. S/he is responsible for ensuring that research conduct and data quality can be monitored and evaluated. The CRA II participates in the design, implementation, maintenance, and reporting of all clinical study activities, interacting with internal and external personnel to facilitate project timelines and ensuring adherence to upper management strategies, GCPs, FDA, and local regulations. S/he may also help evaluate and analyze clinical data, and coordinate activities of associates and investigators.

Job Duties:

* Implement protocols and ensure site and regulatory compliance as well as preparation of required documentation. * Assist with development of CRF and diary, CRF completion guidelines, and study documents. * Assist with writing of protocols and compilation of investigator brochures. * Monitor study site closeout, and data collection/ reconciliation. * Liaise with medical experts, clinical study sites, and CROs as appropriate. * Assist in the preparation of IND, Clinical Study Report (CSR) and other regulatory documents and submissions. * Assist sites with the resolution of data queries and QC clinical study documents. * Contribute in the development of Standard Operating Procedures (SOPs). * Participate in project team meetings and collaborate with key functional team members, i.e. regulatory affairs, quality assurance and data management. * Domestic and/or international travel related to professional responsibilities may account for approximately 10-40% of your annual work time.

Job Qualifications and Professional Characteristics:

* Bachelor’s degree in a scientific discipline, (RN or BSN preferred) or equivalent with a minimum of 2 to 5 years clinical experience. * Satisfactory performance depends on the following skill set: organization and planning, problem solving/decision-making, communication, working relationships, and technical expertise. * Excellent communication and people skills essential. * Collaborative working style, ability create/work in a team environment. * Exceptional people skills. * Strong communicator with excellent written/spoken English and Hindi and a high degree of comfort in dealing with government, media, academic, corporate, nonprofit and other organizations. * Personal values consistent with the mission of iOWH and a willingness to serve further qualify the individual.

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BioTech FYI Center
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