Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you.
Perform, manage and coordinate activities associated with identification of sites for projects or programs.
- Take independent responsibility for assigned site identification projects.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Assists Site ID lead on projects with increased protocol complexity, site numbers and/or customer SOPs or processes.
- Utilizes historic site performance metrics, cluster sites, partner sites, feasibility data, and other data to identify potential sites.
- Submits and reviews investigators for quality assurance status as applicable.
- Tracks all project activities in Quintiles Database system.
- Manages template documents for Confidential Disclosure Agreements (CDAs) and Site Interest Forms (SIFs).
- Distributes tracks and negotiates the Confidential Disclosure Agreements (CDAs) with assistance from Management / QLegal as appropriate.
- Designs, distributes, tracks and reviews Site Information Forms (SIFs) for completeness, site capability and availability.
- Provides project progress reports to Internal and External project teams including department management.
- Adheres to project timelines.
- Contacts Feasibility, Medical Scientific Services and Clinical Operations leads to develop plan for identifying potential sites and processes for assigned projects.
- Review and tier sites for contact based on historical site performance and other required criteria.
- Enter new sites and investigators into the Quintiles Database, reviewing entries for duplicates.
- Transfers applicable data and documentation to Clinical Operations.
- Maintain departmental files, including site list and other project materials as required.
- Responds to site questions about assigned studies in a timely manner.
- Good Knowledge of medical terminology
- Good interpersonal and organizational skills.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Proficient in the use of Microsoft Office.
- Ability to work independently and effectively prioritize tasks.
- Fluent in local language, spoken and written.
- Ability to handle multiple tasks with varying deadlines.
- Familiar with CRO’s and the operation of Clinical Sites.
- Must be highly motivated and organized.
- Ability to maintain confidentiality.
- Ability to establish and maintain effective working relationships with coworkers, managers and customers.
- Bachelors Degree in Health or Biological Science and 2 years’ experience in a healthcare related field; or equivalent combination of education, training and experience.
Quintiles Transnational - 8 months ago
Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it...