Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.
Post: CRA 1-1007337
Job Description:
The CRA conducts monitoring visits for assigned protocols and study sites. Overall responsibilities are to ensure that the study is being conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
- Performs site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
- Provides monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Completes appropriate therapeutic, protocol and clinical research training to perform job duties.
- Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluates the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalates quality issues to Clinical Team Lead and/or Line Manager
- Manages the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution.
- Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
- May provide training and assistance to more junior clinical staff.
Candidate Profile:
- Degree (Bachelor's or Master's) in a scientific discipline
- The candidate must be willing to travel for at least 10 to 12 days in a month, though not necessarily continuous.
- Computer skills including use of a laptop computer, knowledge of Microsoft Word, Excel and PowerPoint preferred.
- Basic knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Strong written and verbal communication skills including good command of English required.
- Excellent organizational and problem solving skills.
- Effective time management skills and ability to manage competing priorities.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Training as Clinical Research Associate in Quintiles as per Quintiles India Clinical Operations Training policy or equivalent work experience in the CRO/pharmaceutical industry
Additional Information:
Experience: min. 1-2 years
Location: Mumbai, Bangalore
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job No.: 1007337
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