Clinical Research Associate

3 weeks ago

Bengaluru, India MS CLINICAL RESEARCH Full time

Job Title: Clinical Research Associate (CRA)


Company: MS Clinical Research Pvt Ltd


About Us:

MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative medical solutions.


Job Summary:

We are seeking a highly motivated and experienced Clinical Research Associate (CRA) with a minimum of 2-3 years of relevant experience. The CRA will play a critical role in ensuring the successful planning, execution, and monitoring of clinical trials. The ideal candidate will have a strong understanding of clinical trial processes, regulatory requirements, and excellent communication and organizational skills.


Key Responsibilities:


Site Management:


Conduct site initiation, routine monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory requirements. Build and maintain strong relationships with investigative sites, investigators, and study coordinators.


Clinical Trial Monitoring:


Perform routine monitoring visits to assess site performance, data integrity, and regulatory compliance. Ensure timely resolution of data queries and issues identified during monitoring visits.


Protocol Compliance:


Ensure that all study activities are conducted in accordance with the approved protocol, SOPs, and applicable regulatory guidelines. Collaborate with investigators to address and resolve protocol-related queries.


Regulatory Compliance:


Assist in the preparation and submission of regulatory documents to ethics committees and regulatory authorities. Stay informed about changes in regulatory requirements and update study teams accordingly.


Data Management:


Collaborate with data management teams to ensure accurate and timely data collection and entry.

Perform source data verification and data validation activities.


Safety Reporting:


Monitor and report adverse events in compliance with regulatory requirements and safety reporting procedures. Ensure that safety reports are submitted to relevant authorities and stakeholders.


Training and Support:


Provide training and support to site staff on study protocols, data collection, and regulatory compliance. Act as a resource for investigators and site staff throughout the duration of the study.


Requirements:


Education: Bachelor's degree in a relevant life sciences field.


Experience:


Minimum of 3 years of experience as a Clinical Research Associate.

Proven track record of successful site management and monitoring in clinical trials.

Regulatory Knowledge: Familiarity with regulatory requirements and guidelines governing clinical trials.


Communication Skills: Excellent verbal and written communication skills.


Organizational Skills: Strong organizational and time management skills with attention to detail.


Team Collaboration: Ability to work effectively in cross-functional teams and independently.


Travel: Willingness to travel to investigative sites as needed.


Benefits:


Competitive salary and benefits package.

Opportunities for professional development and advancement.

Collaborative and dynamic work environment.

Join our team at MS Clinical Research and contribute to the advancement of clinical research and the development of innovative healthcare solutions.

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