PAREXEL Clinical Research Associate Vacancy

PAREXEL International 

Clinical Research Associate II 

Experience: 2 - 3 Years

Location: Bengaluru/Bangalore

Compensation: Rupees 50,000

Education:

UG - B.Pharma - Pharmacy,B.Sc - Biology, Microbiology, Nursing,B.Tech/B.E. - Any Specialization, Bio-Chemistry/Bio-Technology,BDS - Dentistry,BHM,MBBS - Medicine PG - M.Pharma - Pharmacy,M.Sc - Biology, Microbiology, Nursing,M.Tech - Bio-Chemistry/Bio-Technology,M.S/M.D - Cardiology, Dermatology, ENT, General Practitioner, Gyneocology, Hepatology, Immunology, Microbiology, Neonatal, Nephrology, Obstretrics, Oncology, Opthalmology, Orthopaedic, Pathology, Pediatrics, Psychiatry, psychology, Radiology, Rheumatology, Urology

Desired Candidate Profile

Experience:

Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
Strong regulatory knowledge including GCP
Excellent interpersonal, verbal and written communication skills
Sound problem solving skills
Ability to successfully work in a (`virtual) team environment
Sound presentation skills
Consultative skills
Client focused approach to work, ability to interact professionally within a client organization
Ability to prioritize multiple tasks and achieve project timelines
Able to take initiative and work independently.
Sense of urgency in completing assigned tasks
Able to travel a minimum of 65% on average
Holds a driving license where required
Effective time management in order to meet daily metrics or team objectives
Shows commitment to and performs consistently high quality work
Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience
Substantial monitoring experience in clinical research

Job Description

Assume the ability to meet the requirements of a CRA II with a high degree of proficiency and autonomy
Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects
Train team members on selected tasks
Keep manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor.
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 in accordance with the monitoring plan
Conduct on-site study-specific training (if applicable)
Perform site facilities inspection
Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
Monitor and maintain ICH-GCP compliance
Responsible for the completeness and quality of the on-site files
Respond to site issue alerted from Clinical Monitoring Associate (i.e, non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
Collect SRP documents during QV and other 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 ongoing basis
Collaborate with CMA on site issues/actions
Generate visit/contact report in accordance with monitoring plan
Code and scan Central File documents where applicable
Ship relevant wet-ink signature documents to the Assistant or back to the site
Escalate any issues that require immediate action to the CRA Coordinator/GRO Lead
Attend audits / Regulatory Inspection if requested

Further Info on PAREXEL Clinical Research Associate Vacancy