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 closeout activities (remotely/ onsite) 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 kickoff/ investigators 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 & followup 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 problemsolving abilities with a keen eye for detail.
• Result oriented and passionate about delivering value. 

Additional Information :

About the Department
Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cuttingedge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven innovationfocused 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 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 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 Work :

No