PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Senior Clinical Research Associate
Job Description:
Join a team that is recognized not only for our life-changing work, but also for our expertise and breadth of experience Previously, PAREXEL has been named company of the year for the Pharmaceutical Industry in International Business Awards (SM) and ranked as a Best 5 outsourcing company for the Pharmaceutical Industry by The International Outsourcing Professionals.
PAREXEL Contract Personnel Services (CPS) specialises in placing experienced clinical research professionals with top pharmaceutical, biotechnology and medical device companies worldwide. CPS staff are employed on permanent contracts and our dedicated management has extensive experience in clinical research, so we understand the challenges you face as clinical research professionals and can provide you with the greatest opportunities to achieve your personal and professional goals.
Currently CPS is looking for a Senior Clinical Research Associate to join one of the largest most innovative companies in the pharmaceutical arena. This position will be office based in Mumbai, India.
Whilst on assignment, you will receive continued support from a dedicated Manager at PAREXEL. We are committed to supporting professional growth and rewarding excellence and we offer a full performance management and development process providing continuous monitoring and ongoing review of staff performance standards in order to allow staff to reach their full potential. You will also benefit from access to our extensive technical and soft skills training, to help your career growth.
Key Accountabilities:
- Build relationships with investigators and site staff
- Participate in Investigator and other external or internal meetings as required
- Arrange on-site visits and logistics (e.g. travel arrangements)
- Perform on site visits and generate visit/contact reports in accordance with the monitoring plan
- Perform site facilities inspection
- Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
- Responsible for the completeness and quality of the on-site files
- Respond to site issues alerted by the project team (i.e, non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
- Collect SRP documents during site visits as needed
- Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit
- Update all relevant tracking system on an on-going basis
- Code and scan Central File documents where applicable
- Ship relevant wet-ink signature documents to the Assistant or back to the site
- Monitor and maintain compliance with ICH-GCP Guidelines, local regulatory requirements, PAREXEL and/or Client SOPs, and study specific procedures
- Escalate any issues that require immediate action to the CRA Coordinator or COL
- Inform responsible CRA Coordinator/COL/Manager of work status regularly
- Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)
- Perform co-monitoring visits with less experienced CRAs or at problem sites as required
- Function as mentor and role model for less experienced CRAs and/or team members to ensure study specific training
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Benefits
Our success is built on recruiting the best available talent and providing exemplary benefits in an effort to develop long-term relationships. As a CPS employee, the following benefits are available to you:
- Highly competitive salaries
- Expense reimbursement
- Paid holidays, vacation, and other time off
- Work-life balance policy
- Excellent Benefits (tailored by country) including pension, health care, dental care, life insurance, etc
If you would like CPS to review your experience and credentials to be considered for a Clinical Research Associate position, please send your CV along with a cover letter to Sujitra.Sundarasardula@Parexel.com
Qualifications:
- Strong previous experience as a CRA and other relevant clinical research experience.
- University degree in Biological Science/Pharmacy/Nursing or qualification in Nursing
- Knowledge of the Clinical Development process
- Proven track record of demonstrating through knowledge of regional health care environment
- Experience in investigator contract management
- Experience in preparing documents for submission to IRBs/IECs and Competent Authorities
- Computer literacy (e.g. EDC, CTMS, MS office, etc.)
- Excellent verbal and written communication skills in English and local language
- Experience in participating in internal audits is preferred
- Previous involvement in protocol, CRF, or other trial-related development activities preferred
Additional Information:
Location: Mumbai, Maharashtra
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 15th Nov., 2013
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