Axis Clinicals, a prominent player in the clinical research industry, is seeking talented individuals for the roles of Clinical Research Associates II and III in Hyderabad. This is an exciting opportunity for professionals with a background in life sciences and on-site clinical trial monitoring experience. Read on to learn more about the qualifications, job responsibilities, and application process for these roles.
About Axis Clinicals
Company Overview
Axis Clinicals is a leading contract research organization (CRO) that provides comprehensive clinical trial services to the pharmaceutical, biotechnology, and medical device industries. With a strong commitment to quality and compliance, Axis Clinicals has established itself as a trusted partner in clinical research.
Job Role: Clinical Research Associates II, III
Position: Clinical Research Associates II, III
Location: Hyderabad
Experience: 2+ years of on-site clinical trial monitoring experience
Qualification: Bachelor's or Master's degree in biological/life sciences, pharmacy, or other health-related disciplines
Key Responsibilities:
Site Feasibility
- Contact potential investigators to discuss study details and obtain critical feedback to assess study feasibility.
- Prepare and support regulatory and ethics committee submissions, ensuring timely collection of documents.
- Initiate, monitor, and close out investigational sites.
- Attend staff meetings and training sessions to complete the training curriculum in a timely manner.
- Assist with site or central file audits and liaise with Quality Assurance personnel to ensure compliance with ICH GCP guidelines.
- Ensure timely and accurate investigator payments.
- Build and maintain effective relationships with investigational sites.
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Axis Clinicals Hyderabad Hiring Clinical Research Associates II, III[/caption]
Clinical Monitoring Activities
- Prepare presentation materials for investigator meetings to ensure that clinical and investigational site staff are well-informed about study procedures.
- Ensure site personnel understand the protocol, investigational product, and study requirements to conduct the study accurately and on time.
- Address any protocol non-compliance issues with the principal investigator.
- Provide ongoing training to site personnel on applicable guidelines and AXIS SOPs to maintain data quality and integrity.
- Coordinate the supply and disposal of clinical materials to the site for timely patient recruitment post-ethical approval.
- Collaborate with other departments (e.g., Medical/Pharmacovigilance, Regulatory) to ensure compliance with serious adverse event reporting requirements.
- Perform site visits to ensure protocol adherence and document any issues in visit reports for timely resolution.
- Prepare and submit visit reports in a timely manner as per AXIS SOPs or contract requirements.
- Interact with investigators to obtain necessary documentation and information throughout the study.
- Maintain accurate inventory of central, investigator site, and core files to ensure quality and reference usability.
- Perform ongoing on-site data management to communicate data quality issues early and maintain close contact with Data Management.
- Maintain project tracking systems (CTMS or client equivalent, Patient Recruitment Plan, etc.) to track site progress and provide status updates to the Project Manager, CL, and client.
- Complete routine administrative tasks in a timely manner (e.g., timesheets, metrics, travel expense claims).
Qualifications and Skills
To be eligible for the Clinical Research Associates II and III positions, candidates should possess:
- Educational Background: A Bachelor's or Master's degree in biological/life sciences, pharmacy, or other health-related disciplines.
- Experience: 2+ years of on-site clinical trial monitoring experience with a CRO.
- Technical Skills: Proficiency in clinical trial management systems and regulatory requirements.
- Communication Skills: Strong verbal and written communication skills.
- Attention to Detail: Exceptional attention to detail and organizational skills.
Why Join Axis Clinicals?
Career Growth
Axis Clinicals offers ample opportunities for professional development and career advancement. As a Clinical Research Associate, you will work on diverse clinical projects and enhance your expertise in clinical research.
Innovative Environment
At Axis Clinicals, we foster a culture of innovation and excellence. You will be part of a dynamic team dedicated to advancing clinical research.
Global Exposure
Working at Axis Clinicals provides you with the opportunity to collaborate with international teams and gain valuable experience in global clinical research.
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How to Apply
Interested Candidates
If you meet the qualifications and are excited about the opportunity to join a leading CRO, send your CV to
Sampathkumar.p@axisclinicals.com
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https://pharmastuff.org.in/job/axis-clinicals-hiring-clinical-research-associates
