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

• Responsibilities

• Facilitate Study Start up activities at Clinical Investigational Site
• Conduct Feasibility & assess the data
• Conduct site qualification visits to assess suitability of sites for study conduct including review of Investigator qualifications site staff adequacy site facilities patient pool & share feedback to project team
• Collection of essential documents including validation records for site equipment from selected sites for regulatory and EC submissions
• Identify the training needs for the site to perform adequate conduct of trial
• Ensure supply of clinical trial material to sites before study initiation
• End to End clinical investigational site management:
• Initiate the study at clinical investigational sites
• Provide study protocol and related trainings
• Perform review of Informed Consent forms and narrative
• Perform review of source records perform SDV
• Review of CRF data entry data queries and coordinate with sites to resolve
• Ensure timely completion and review of site visit reports and addressing action items via follow up letters tracking of action items till closure
• IP accountability and reconciliation
• Ensure adequate initial supply & resupply of IP per study plan to clinical trial sites
• Provide adequate oversight to IP collection storage temperature monitoring including review of log administration to study subjects
• Identification of any temperature excursions and suitability of IP for subject administration
• Ensure destruction of expired / used IP on site or return of such IP back to local depot per study requirement & adequate documentation for same.
• Review of completion of logs filing of relevant shipment etc. documentation in site / pharmacy file.
• Site Contracts and Site Payment Coordination
• Coordinate for CDA Clinical trial agreements review and finalization and amendments as applicable
• Ensure that site invoices are being generated as per clinical trial agreement
• Review and approval of site invoices and submission to payment processing team
• Coordinate for the payment release & confirm for site acknowledgements
• Perform ongoing reconciliation of payments against site activities including subject visits conduct etc.
• Liaising with safety lab for timely samples receipt processing and release of reports & identify resolve any issues / risks around same.
• Ensure that the Bioanalytical samples are stored as per storage conditions mentioned in the lab manual including reconciliation and query resolution
• Liaising with other vendors and help sites in any query resolutions for vendor related activities
• Liaising with internal project teams including but limited to Data Management for EDC issues data queries and reconciliations Safety team for SAE related issues Medical team for any protocol / eligibility related queries etc.
• Liaising with Internal & External Stakeholders
• Ensuring Compliance to Protocol & Applicable study plans SOPs GCP and regulatory requirements
• Ensure compliance to Protocol
• Ensure compliance to study plans applicable SOPs and related regulatory requirements
• Ensure compliance to ICH GCP
• Ensure compliance to good documentation practices including ALCOAC
• Identification of significant deviations to protocol / plans / procedures escalation to project lead / clinical ops lead and propose adequate mitigation plans / CAPA Review of implementation of CAPA / mitigation plans identify need for training and provide training / retraining in case of any changes
• Support audits inspections / QC visits as required per study plans
• Trial Master File Review and Maintenance for Inspection Readiness
• Ensure that sites are timely updating the documents in Investigator site file
• Retrieval of essential documents from sites for In house filing / Central files
• Review of onsite and in house files at defined frequency per monitoring / TMF plan for study
• Ensure adequacy of TMF for all time inspection readiness

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 !/ 

Remote Work :

No

Employment Type :

Fulltime