Website Dr. Reddy’s Laboratories
Post Name: Clinical Research Associate
Job Summary:
We are seeking a dynamic independent and experienced Research Associate in Clinical Management for processing, reviewing and receiving clinical data and records and 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 to monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols under supervision of Clinical Operations Manager/ Clinical Research Specialist.
Responsible to perform study site feasibility, qualification, initiation, monitoring and close-out activities (remotely/ on-site) under supervision in line with study specific project management/ sponsor oversight plan and apply judgment and knowledge to independently resolve site issues, questions, and concerns.
Support Clinical Operations Manager/ Clinical Research Specialist to prepare for project kick-off/ investigator’s meeting.
Will be desirous to build and maintain relationships with investigators and site staff.
Will be responsible to address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation and communication.
Responsible for documentations under supervision and ensure maintenance of Trial Master File/ Sponsor Oversight File in line with study specific project management/ sponsor oversight plan.
Support study sites in making Ethics Committee submissions under supervision in line with study specific project management/ sponsor oversight plan.
Responsible to review & follow-up on site payments.
Assist with data query resolution process for site, Clinical Research organisation (CRO) and Sponsors along with Clinical Data Management in line with study specific project
management/ sponsor oversight plan.
Responsible to work collaboratively with the study teams with the review, revision and writing of protocols, Case Report Forms (CRF) and other required documents for clinical research studies.
Qualifications:
Educational qualification: Master 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.
