KlinEra has been partnering with pharmaceutical, biotech and device companies since 1999, providing innovative and customized clinical services to their client’s. Today, a decade’s presence in the Clinical Research Arena has made it a mature, comprehensive, creditworthy clinical research organization with offices in Mumbai, India and in San Jose, CA, USA. KlinEra offers a broad spectrum of integrated clinical research services through its dedicated and robust team of accomplished clinical researchers and optimizing cutting edge resources to cater to diverse global demands.
Post: Senior Clinical Research Associate
Job Description:
Conduct Site Feasibility: Responsible for identifying sites based on prior experience and therapeutic area expertise. Conducting detailed feasibility by completing site feasibility questionnaires, site selection visits and ensuring that the site has capability, experience and the infrastructure required for conducting clinical studies.
Attending and arranging Investigators Meetings: Responsibilities include coordinating the Investigators meeting, preparing required protocol and site training materials and ensuring attendance of key members from the study sites.
GCP Training: Providing GCP training to sites during the Investigator’s Meeting, Site Initiation visit and as required during the course of the trial. Training is provided to sites on both FDA and Indian regulatory agency (DCGI) requirements.
Submissions to Regulatory Agency and Ethics Committees: Compiling and reviewing the submissions to DCGI in India and the site Ethic’s Committees (EC’s).
Compile and Review Clinical Trial Master File and Site Regulatory Binders : Ensuring that Clinical Trial Master File and the site regulatory binders are compiled per SOP’s and regulatory requirements and all the essential documents are current and complete.
Site Initiation visits: Responsibilities include training on study protocol and processes
Site Selection visits: Conducting site selection visits based on the feasibility studies and ensuring that the site meets all the regulatory, infrastructure and clinical trial requirements.
Site Monitoring visits: Responsibilities include conducting the activities per the study monitoring plan:
Klinera Quality, Sponsor and Regulatory Audits: Responsibilities include preparing sites for the Klinera quality (Klinera conducts internal audits on all on going trials), sponsor or regulatory agency audits.
Site Close-out visits: Responsibilities include preparing the site for study closeout.
CRA training and Co-monitoring: Responsible for conducting training and co-monitoring visits with junior CRA’s to ensure that all the above referenced trial activities are conducted per regulatory, study and sponsor requirements.
Overall Study Management: Responsible for oversight of all trial activities and maintaining study trackers and timelines. Supporting Clinical Project Manager in training and compliance as required.
Candidate Profile:
*Recent Cardiovascular trial experience preferred
*Must have previous experience as a field CRA
*Cardiovascular clinical knowledge preferred
*Requires hands-on clinical research experience encompassing all aspects of the clinical study process
*4 years experience in clinical research industry (CRO or Pharmaceutical Company) with at least 2 years field monitoring experience
*A bachelor's degree in a related biological or life science discipline or B. Pharm.
*B.A.M.S or B.H.M.S. will be preferred. Clinical research Certification strongly preferred
Additional Information:
Experience: 3-5 years
Location: Mumbai
Education: B.Pharm, BAMS, BHMS, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area : CR
End Date: 30th Jan, 2012
To Apply/Send resume, info@klinera.com
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