Life Sciences Senior CRA Role at Makro Care – Apply Online

Makro Care CRA Jobs For Life Sciences – Apply Online

Makro Care CRA Jobs For Life Sciences – Apply Online. Life Sciences Senior CRA Role at Makro Care – Apply Online. CRA jobs Makro Care. MSc, BSc Life Sciences jobs at Makro Care. The latest role for Senior CRA in Makro Care check out all the details given the same below

Job Title: Senior CRA

Job Location: Hyderabad

Industry Type: Pharma / Biotech / Clinical Research

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

APPLY ONLINE

Possible interview questions may be asked for Senior CRA in Marko Care 

1. Can you explain your experience in site identification, qualification, and investigator selection in compliance with ICH-GCP requirements? Answer: Certainly! In my previous role as a Clinical Research Associate, I was responsible for identifying potential study sites, ensuring their qualification, and selecting suitable investigators in alignment with the sponsor’s protocol and ICH-GCP requirements. I accomplished this by conducting thorough site assessments, reviewing their capabilities and resources, and ensuring they meet the necessary regulatory standards.

2. How do you ensure the adherence of study staff to good clinical practices (GCP) and the study protocol during monitoring visits? Answer: During monitoring visits, I emphasize the importance of GCP compliance and adherence to the study protocol to the study staff. I conduct thorough training sessions to reinforce their understanding of these guidelines and their role in ensuring data accuracy and subject safety. Additionally, I review their documentation and records to identify any deviations and address them promptly.

3. How do you manage study/project timelines and ensure timely updates to the system used for tracking progress? Answer: Time management is crucial in clinical research. I maintain a detailed study/project timeline, and I regularly communicate with the study team and principal investigators to track progress. I use study tracking tools to ensure real-time updates are made, allowing us to stay on schedule and meet important milestones.

4. Can you provide an example of a challenging situation you encountered during a clinical trial and how you resolved it? Answer: During one of my clinical trials, there was an unexpected delay in patient recruitment due to unforeseen recruitment challenges at a particular site. To address this, I collaborated with the site staff to identify the root cause of the issue and developed a proactive recruitment strategy. By implementing targeted outreach and enhancing patient engagement, we successfully accelerated recruitment and met the enrollment target.

5. How do you ensure the accuracy and completeness of clinical trial documentation, including protocols, CRFs, and ICFs? Answer: Maintaining accurate and complete documentation is crucial for successful clinical trials. I conduct meticulous reviews of all trial documents to ensure they align with the study protocol and regulatory requirements. Additionally, I collaborate with the data management team and investigators to address any discrepancies or missing information promptly.

Editor’s Note: Makro Care CRA Jobs For Life Sciences – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.