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Makro Care CRA Jobs For Life Sciences – Apply Online
Job Title: Senior CRA
Job Location: Hyderabad
Job ID: 51059
Company Description
MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion. MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
Job role & responsibilities:
- Site identification, site qualification and investigator selection in compliance with sponsor protocol and ICH-GCP requirements.
- To provide GCP training to the study staff. Coordinating and organizing the study investigator meetings, interim, coordinators meetings and its documentation (MOM).
Clinical trial monitoring visits, preparation and submission of monitoring report to the Team Lead- Clinical Operations. - Verification of clinical trial documents which includes protocols, CRFs, ICF, and IRB documentation.
- Verification of pharmacy records, drug dispensing and drug accountability records, study randomization plan as per the study protocol, ICH GCP, applicable regulatory requirements and governing SOPs.
- Ensure that the environmental conditions are maintained inside the pharmacy (i.e. Temperature logers, Humidity logers).
- Ensure that all the data queries are addressed to Team Lead – Clinical Operations, documented and resolved with in the specified timelines.
- Monitoring that investigator and study staff adheres to good clinical practices, the study protocol and governing SOPs.
- To make regular contacts with the principal investigator or other site staff members during the course of the studies, to ensure all is proceeding to agreed protocols and the time schedules and that the data is being recorded accurately and returned to the required timescales.
- To review all data produced from each study and resolve any data queries/protocol deviations identified.
- To conduct source data verifications as required to data monitoring guidelines. Work with the safety officers to clarify, respond to, and resolve adverse events as they rise.
- To ensure that data is provided to the data manager in a timely manner for databasing.
To track the study progress using the study tracking tools, ensuring timely and quality updates to the system used.
It is expected that the post holder will perform duties without direct supervision and will be self-directed in terms of time and workload management.
Duties include site monitoring, Patient recruitment & retention & Site relationship development, Study/project timelines management, Documents/ TMF management, and site training.
Education & Experience:
- Graduate/Post graduate degree in a scientific or pharmacy or life sciences or medical discipline
- Able to understand the ICH-GCP requirements and clinical research regulations is preferred
- Professional use of the English language; both written and verbal
- 4– 8 Years of work experience of CRA within CRO/Clinical Trials.
- A keen ongoing interest in clinical research, pharmaceuticals and regulatory affairs is essential for maintaining quality performance in this position
- Continuing education in these areas is encouraged & Strong attention to detail is a MUST
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