Study Co-ordinator - AP
Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
Acts as a liason between lab operations and the sponsor to ensure coordination of study logistics. Responsible for ensuring the study documentation is accurate, complete, and well organized in accordance with internal and regulatory standards.
Coordinates with internal and external stakeholders to schedule and execute study set up, site initiation and qualification visits as detailed in the protocol documentation.
Organizes documentation from lab analysis in study binder.
Ensures study documentation is complete and accurate.
Plans and hosts monitoring visits with sponsors.
Responsible for follow up on sponsor visit findings to ensure appropriate resolution.
Files deviation documentation, as needed.articipate in investigation and resolution.
Ensures effective communication between the sponsor and lab operations related to study.
Attends study calls to stay abreast of study needs and ensures follow up on assigned actions.
Ensures adequate inventory of reagents for training and sample analysis.
Coordinates training for lab staff to ensure competency and regulatory requirements are met.
Partners with management to ensure training records for lab staff dedicated to the study are up to date.
Partners with lab management to ensure sample analysis in accordance with study timelines.
Ensures effective coordination of multiple studies to ensure regulatory compliance and sponsor expectations are met.
Identifies opportunities for process improvement and suggests best practices for effectiveness.
Responsible for supporting six sigma, quality, and safety initiatives.
Recognized specialist that works under moderate supervision to deliver on operational targets and standards. Achieves operational targets that impact results for the team. May guide other team members within the area.
Responsible for identifying opportunities for process improvement, working with senior staff on implementation.
May partner with senior level staff to communicate with client on routine inquiries.
Bachelors degree in a relevant scientific discipline plus 1 year experience in a regulated laboratory environment; or equivalent combination of education, training and experience operating under applicable quality management/regulatory guidelines or Associates plus 3 or equivalent experience.
Sound knowledge of good documentation practices
Working knowledge of laboratory workflows
Proficiency in standard computer operating systems and navigating file based transfer systems
Strong interpersonal, communication, organizational, and time management skills, Demonstrated ability of critical thinking and problem solving.
Strong written and verbal communication skills including good command of English language.
In certain geographies where communication in local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred.
Demonstrated ability to handle multiple competing priorities; utilize resources effectively.
Strong attention to detail and accuracy. Demonstrated ability to work in a fast-paced, high stress environment highly desirable.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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