Clinical Research Associate
- Dr Reddys
- 3 - 6 years
- Hyderabad
- 8 months ago
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Job Description
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
- You will be 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.
- You will be 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.
- You will support Clinical Operations Manager/ Clinical Research Specialist to prepare for project kick-off/ investigators meeting.
- You will be desirous to build and maintain relationships with investigators and site staff.
- You will be responsible to address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation and communication.
- You will 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.
- You will Support study sites in making Ethics Committee submissions under supervision in line with study specific project management/ sponsor oversight plan.
- You will be responsible to review & follow-up on site payments.
- You will 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.
- You will be 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.
- Experience in handling sites for Phase clinical trials and Patient Based PK Studies are preferred
Educational qualification: Master degree in pharmacy/ life science/Biology/Biotechnology/ Biochemistry/Diploma in Clinical ResearchMinimum work experience: 2 - 5 years of research experienceSkills & 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.
- Experience in handling sites for Phase clinical trials and Patient Based PK Studies are preferred
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.
About the Department
Integrated Product Development Organisation
We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say, because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and were always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & DevelopmentRole Category: Pharmaceutical & BiotechnologyRole: Pharmaceutical & Biotechnology - OtherEmployement Type: Full timeContact Details:
Company: Dr ReddysLocation(s): Hyderabad
Keyskills: standard operating procedures project management pharmaceutical analytical edc interpersonal skills medical terminology market research data collection research clinical system management gcp clinical research negotiation clinical trials communication skills ms office
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