Quintiles is the world’s leading provider of biopharmaceutical services. With a network of more than 27,000 professionals working in more than 80 countries, we have helped develop or commercialize all of the top 50 best selling drugs on the market. With extensive therapeutic, scientific and analytics expertise, we help biopharmaceutical and health sciences customers navigate the increasingly complex landscape with more predictability to enable better outcomes.
Job Title : Clinical Research Associate
Job Description :
Conduct monitoring visits for assigned protocols and study sites.
Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
Job Responsibilities :
Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
May provide assistance to less experienced clinical staff.
All responsibilities are essential to job functions unless noted as non-essential (N).
Desired Profile :
Education and Experience :
Bachelor's degree in a health care or other scientific discipline or educational equivalent and successful completion of a CRA Trainee Program or 3+ months of on-site monitoring experience; or equivalent combination of education, training and experience.
Skills and Abilities :
Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Good therapeutic and protocol knowledge as provided in company training
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a lap top computer
Good written and verbal communication skills including good command of English language
Good organizational and problem-solving skills
Effective time management skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
How to Apply :
Interested candidates can apply online using the link below :
APPLY ONLINE HERE
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