Dr Reddy’s Clinical Research Associate Job For Life Sciences, Apply Now
Dr. Reddy’s Laboratories
Clinical Research Associate
Hyderabad, Telangana, India
Job Summary
We are seeking a dynamic, independent, and experienced Research Associate in Clinical Management for processing, reviewing, and receiving clinical data and records from therapeutic groups as well as internal and outside investigators. Ensuring accurate, timely, and consistent data reaches the clinical teams and other groups.
Roles & Responsibilities
- Responsible for monitoring activities at clinical study sites to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols under the supervision of the Clinical Operations Manager/Clinical Research Specialist.
- Responsible for performing study site feasibility, qualification, initiation, monitoring, and close-out activities (remotely/on-site) under supervision, in line with the study-specific project management/sponsor oversight plan, and applying judgment and knowledge to independently resolve site issues, questions, and concerns.
- Support the Clinical Operations Manager/Clinical Research Specialist in preparing for project kick-off/investigator meetings.
- Will be desirous to build and maintain relationships with investigators and site staff.
- Will be responsible for addressing and resolving issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
- Responsible for documentation under supervision and ensuring maintenance of the Trial Master File/Sponsor Oversight File in line with the study-specific project management/sponsor oversight plan.
- Support study sites in making Ethics Committee submissions under supervision, in line with the study-specific project management/sponsor oversight plan.
- Responsible for reviewing & following up on site payments.
- Assist with the data query resolution process for sites, Clinical Research Organizations (CROs), and Sponsors, along with Clinical Data Management, in line with the study-specific project management/sponsor oversight plan.
- Responsible for working collaboratively with the study teams in reviewing, revising, and writing protocols, Case Report Forms (CRF), and other required documents for clinical research studies.
Qualifications
Educational Qualification: Master’s degree in Pharmacy/Life Science/Biology/ Biotechnology/ Biochemistry/ Diploma in Clinical Research.
Minimum Work Experience: 2 – 5 years of research experience.
Skills & Attributes:
Technical Skills
- Experience in Clinical Trial operations.
- Proficiency in conducting market research and analysis.
- Knowledge of regulatory requirements and guidelines such as Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Ability to evaluate medical research data and proficient knowledge of medical terminology.
- Proficiency in using EDC systems for data collection and management in clinical trials.
- Understanding of pharmacovigilance processes.
- Strong MS Office skills.
Behavioral Skills
- Excellent communication, negotiation, and interpersonal skills.
- Excellent project management skills.
- Strong analytical and problem-solving abilities with a keen eye for detail.
- Result-oriented and passionate about delivering value.
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