Sr. Clinical Research Associate

1 month ago

Bengaluru, India Syngene Full time

Job Location:  Bangalore

Department:  Clinical Operations

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation .

Job Description:

Role:

Senior Clinical Research Associate/Clinical Research Associate 

Key Responsibilities:

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work, Standard Operating Procedures and all the applicable Good Clinical Practice (GCP) Guidelines and Regulations. Responsible for site management for the assigned protocols, sites and therapeutic areas Complete appropriate Standard Operating procedure training, therapeutic area training, protocol training and any relevant training required to perform job duties Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectation and activities  Ensure the quality and integrity of study conducted at site level in accordance with protocol and applicable regulations. Investigate and discuss quality issues with Clinical Project Manager for resolution and implementation of Corrective Action and Preventive Action Manage the progress and performance of the assigned study sites by following activities but not limited to: tracking regulatory and Ethics Committee submissions and approvals, subject recruitment, case report form (CRF) completion and submission, and data query generation and resolution.  Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentations.  Provide assistance to the Clinical Project Manager with design of study tools, documents and processes. Timely submission of timesheets for Project specific and other tasks. Assignment as a Lead Clinical Research Associate (if required), the responsibilities could include: Supporting the Clinical Project Manager for coordination with-in the project team.  Delegation of project level Clinical Project Manager responsibilities The above responsibilities would be assigned by reporting manager and project-level task allocation would be performed.

Educational Qualification: 

M. Sc/M. Pharm/Pharm D, BAMS, BDS, MDS & BHMS/Any life science 

Experience: 

3 - 9 Years

Behavioural Skills:

Should have good communication skill and should be a good team player. Ability to work successfully in a dynamic, ambiguous environment. Ability to meet tight deadlines and prioritize workloads. Ability to develop new ideas and creative solutions. Should be a focused employee.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

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