As the global pioneer in pharmaceutical services, Quintiles helps deliver new drugs and cures for the world’s most challenging diseases.
We are 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. Current Vacancy:
Post: Research Coord-1009957
* Collect, compile, document
, support and analyse, clinical research data via remote site monitoring.
* Ensure investigative sites are working in accordance with protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
* May be responsible for the remote monitoring of one or more projects. May be proposed to work as a Technical Solutions Specialist.
* Collect, track and review study site critical documents used to monitor interest for enrollment of investigative sites.
* Ensure compliance with protocol guidelines and requirements of regulatory agencies, including the provisions of the Anti- Kickback Statute (USA) and the False Claims Act (USA).
* Thoroughly document and track all communication (email, voice, fax, call reports) with all study site personnel and any client interaction in accordance with study plans.
* May assist in the development of site specific recruitment, retention and follow up plans / processes in line with the project strategy provided by Project Coordination Centre (PCC) Lead. Ensure the site is recording data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources in accordance with study plans.
* Follow established guidelines in the collection and tracking of clinical data and resolution of data queries in accordance with study plans and client preferences. Evaluate and assure quality of data collected; ensure that all data and study documents are handled consistently with the demands of regulatory agencies with respect to data protection.
* Identify problems and/or inconsistencies; monitor site and subject progress, including documentation and reporting of adverse events; recommend corrective action as appropriate; escalate to PCC Lead or line manager as appropriate
* Respond to questions on study procedures/protocol via the study hotline.
* Liaise and work in conjunction with CRAs monitoring on-site as needed. Perform on-site co-monitoring and remote monitoring activities as needed.
* Provide guidance to PCC Clinical Assistant staff as needed.
* Research Coordinators working as Technical Solutions Specialists will be required to provide solutions to support the efficient use of clinical systems and applications, the compliance with Quintiles PCC standard processes and the overall quality of the project deliverables. They will be required to work globally with project team members and business units to streamline reporting and automate processes to produce quality and lower cost deliverables and to participate in global initiatives that advance PCC innovation, under the direction of the Head of Technical Solutions.
* All responsibilities are essential job functions unless noted as nonessential (N). REQUIRED KNOWLEDGE, 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 Harmonisation (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
* Ability to manage competing priorities
* Strong interpersonal and organizational skills
* Strong written and verbal communication skills including good command of English language
* Strong attention to detail
* Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
* Bachelor’s degree in a health care or other scientific discipline or educational equivalent and less than 1 year of on-site monitoring experience; or equivalent combination of education, training and experience
* 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 Occasional travel Approvals
Primary Location : IND-Karnataka-Bangalore
Other Locations: IND-Maharashtra-Mumbai
Organization: IND02 – India – CDS/Product Devel
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