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 organizations clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
1) On time completion of assigned role specific trainings (self-learning courses, instructor led training, acknowledgement of e-SOP/WI etc.) and related assessment
2) Under no to minimal supervision perform centralized monitoring activities for the assigned projects which includes but is not limited to:
a. Loading and maintaining the working databases with details of participating sites
b. Coordinating for needful accesses for the site, clinical and project management teams
c. Ensuring on-time completion of documentation(s) that form a part of the regulatory dossier for kit and sample shipment
d. Ensuring on-time release of correct, complete and accurate patient laboratory report by following up on the associated pending activity(ies) and related team(s)
e. Ensuring that documentation is available for all activities performed for real-time audit readiness
f. Participation in departments initiatives/drives as applicable
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
1) Basic knowledge of applicable research and regulatory requirements, i.e., ICH GCP and relevant local laws, regulations and guidelines
2) Excellent skills in MS Applications (Microsoft Word, Excel and PowerPoint)
3) Excellent analytical skills
4) Excellent verbal and written communication skills
5) Excellent data entry skills
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
1) Minimum bachelors degree in life sciences/ pharmacy/allied fields
1) Extensive use of keyboard requiring repetitive motion of fingers.
2) Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
3) Regular sitting for extended periods of time.
4) May require working in shifts.
Job ID: R1062120