Clinical Research Associate
2 - 5 YearsMumbai
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Posted: 5 days ago
Job Description
PAREXEL provides monitors with
world class technology, training resources, and limited protocol load.
You will also be rewarded for your hard work through our CRA bonus
incentive program and career advancement opportunities.
Your Key Accountabilities:
Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL's standard operating procedures
Act as PAREXEL's direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites
Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Function as a mentor and role model for other CRA team members
Manage clinical monitoring activities, including:
Arranging on-site visits and logistics
Establishment of a site recruitment plan in collaboration with site staff during QV
Monitoring completeness and quality of Regulatory Documentation
Performing site documentation verification
Data collection and drug accountability in accordance with ICH GCP guideline
Monitoring patient safety on-site and addressing any violations in a timely manne
Salary: Not Disclosed by Recruiter
Industry: IT-Software / Software Services
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Clinical Research Associate/Scientist
Role: Clinical Research Associate/Scientist
Keyskills:
Your Key Accountabilities:
Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL's standard operating procedures
Act as PAREXEL's direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites
Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Function as a mentor and role model for other CRA team members
Manage clinical monitoring activities, including:
Arranging on-site visits and logistics
Establishment of a site recruitment plan in collaboration with site staff during QV
Monitoring completeness and quality of Regulatory Documentation
Performing site documentation verification
Data collection and drug accountability in accordance with ICH GCP guideline
Monitoring patient safety on-site and addressing any violations in a timely manne
Salary: Not Disclosed by Recruiter
Industry: IT-Software / Software Services
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Clinical Research Associate/Scientist
Role: Clinical Research Associate/Scientist
Keyskills:
Desired Profile
Your Skillset:
Minimum 2 years of monitoring experience in clinical research
Educated to degree level (biological science, pharmacy or other health related discipline)
Strong working knowledge of EDC systems and IVRS
Experience of CTMS preferred
Competent in written and oral English and local language Our Offer:
We offer you a fascinating and diversified insight into PAREXEL and an exciting journey through the world of clinical research.
You can expect to work with a successful, highly-qualified and dynamic team as you develop your individual scientific profile. You can also look forward to a flexible working environment and a pleasant atmosphere.
If you are ready to join PAREXELs Journey, please apply
Education:UG -B.Pharma - Pharmacy
PG - Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Minimum 2 years of monitoring experience in clinical research
Educated to degree level (biological science, pharmacy or other health related discipline)
Strong working knowledge of EDC systems and IVRS
Experience of CTMS preferred
Competent in written and oral English and local language Our Offer:
We offer you a fascinating and diversified insight into PAREXEL and an exciting journey through the world of clinical research.
You can expect to work with a successful, highly-qualified and dynamic team as you develop your individual scientific profile. You can also look forward to a flexible working environment and a pleasant atmosphere.
If you are ready to join PAREXELs Journey, please apply
Education:UG -B.Pharma - Pharmacy
PG - Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Company Profile
PAREXEL International Corporation is a
leading global bio/pharmaceutical services organization, providing a
broad range of knowledge-based contract research, consulting, and
medical communications services to the worldwide pharmaceutical,
biotechnology and medical device industries. Committed to providing
solutions that expedite time-to-market and peak-market penetration,
PAREXEL has developed significant expertise across the development and
commercialization continuum, from drug development and regulatory
consulting to clinical pharmacology, clinical trials management, medical
education and reimbursement. Perceptive Informatics, Inc., a subsidiary
of PAREXEL, provides advanced technology solutions, including medical
imaging, to facilitate the clinical development process. Headquartered
near Boston, Massachusetts, PAREXEL operates in approximately 70
locations throughout over 50 countries around the world, and has more
than 13,000 employees. At PAREXEL, we have a passion for making a
profound difference. As an expertise-based business, the caliber of our
people and their dedication directly impacts our success, the success of
our clients, and the ability to make a difference in the lives of
patients worldwide. You'll be surrounded by supportive leadership and a
brilliant team who share a common goal - to improve the lives of
millions of patients.
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