Job title: Senior Clinical Research Associate
Company: Sygene
Job description: Designation: Sr. CRA
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 Purpose:
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
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:
B. Pharm/M. Pharm/BAMS
Technical/functional Skills:
- Regulatory knowledge
- Monitoring skills
- operational skills
- Job knowledge and needs to work according to the requirement
Experience:
6-9 years
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.
,
Other details
Expected salary:
Location: Hyderabad, Telangana – Andhra Pradesh
Job date: Tue, 14 Dec 2021 08:55:06 GMT
Apply for the job now!