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.
Post: Sr. Clinical Research Associate-1405620
Job Description
Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
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.
- Act as a mentor for new clinical staff.
- May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes.
All responsibilities are essential to job functions unless noted as non-essential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- In depth 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 laptop computer
- Strong written and verbal communication skills including good command of English language
- Excellent organizational and problem-solving skills
- Strong time management skills
- Ability to manage competing priorities
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
Candidate Profile
Bachelor's degree in a health care or other scientific discipline or educational equivalent and 3 years of on-site monitoring experience; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
Additional Information:
Experience: Min. 3 year
Qualification: B.Pharm, B.Sc
Last Date: 28th September, 2014
Job Id: 1405620
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