Clinical Research Associate (CRA)
Clinical Research Associate (CRA)
Parexel
Job description
Looking for a role where you focus on supporting the preparation of clinical trial sites and the coordination of regulatory documents? Find out more about the Clinical Research Associate role at Parexel, Bengaluru, India.
Company Description
Parexel is a multinational life sciences industry clinical development and consulting organization. The company has more than 22,000 people throughout the world and works with biopharmaceutical companies and research sites to develop and run clinical studies. It focuses on patient-centered research, regulatory compliance, and support to develop innovative medicines.
Job Summary
This candidate will be responsible for managing clinical trial start-up, pre-site initiation visit (Pre-SIV) and site activation activities. The Clinical Research Associate is the principal contact for assigned research locations and manages documentation, regulatory submissions and preparedness needs. The position will also include troubleshooting site-related difficulties, keeping trial records and working with internal and external teams to enable compliance and timely study initiation. The role is available on a hybrid/on-site basis.
Key Responsibilities
Collaborate with assigned clinical research sites, investigators and site staff during study start-up and activation phases.
Support nation specific feasibility assessment and site qualification operations, e.g. confidentiality agreements, qualification visits.
Develop and co-ordinate the preparation, distribution, collecting and assessment of regulatory documentation to be submitted at country and site level.
Review and negotiate the Informed Consent Forms (ICFs), translations and revisions as per applicable regulatory standards.
Preparation and submission of applications to Institutional Review Boards (IRBs), Independent Ethics Committees (IECs) and applicable health ministries or regulatory agencies.
Follow up on regulatory queries and open requirements until the required permissions are received.
Accurately enter study start-up and amendment data into the Clinical Trial Management System (CTMS).
Identify and mitigate any risks to the site activation time frame, recruiting plan, personnel training and regulatory compliance.
Support internal and external meetings and assist in site readiness for audits and inspections.
Work independently, communicate progress to management and report any potential risks, delays and operational difficulties on time.
Educational Qualification
Bachelors' degree in Biological Sciences, Pharmacy or other health related area.
Skills Required
Extensive experience in clinical trial start-up or equivalent clinical research activities.
Knowledge of clinical trial technique, terminology and operational processes.
Knowledge of International Council for Harmonization Good Clinical Practice (ICH-GCP) guidelines and regulations needed.
Excellent writing and verbal communication abilities to interface with clinical locations and internal stakeholders.
Detail oriented with a commitment to correct documentation and compliance with regulatory requirements.
Ability to work independently and exercise good judgment, and to manage competing priorities.
Experience with regulatory affairs, site management, international regulatory requirements, multi-country research, site initiation/activation processes.
Salary Structure
The average salary of a Clinical Research Associate in India is between ₹6- 9 Lakhs per year.
Career Development
At Parexel, clinical research professionals have the opportunity to move into senior CRA roles, specialized technical responsibilities, project management, subject-matter knowledge and people management. Study start-up and regulatory coordination experience may also be useful in developing expertise in clinical trial operations.
How to Apply
Go to our job portal and look for the Clinical Research Associate(CRA) vacancy.
Read through all eligibility requirements and responsibilities on the job listing.
Fill up the information and submit your updated resume.
Confirm your application details and submit your application.
Education
Bachelor's Degree
Key Skills
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