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.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/