Sr Lab Project Svcs Coord

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.

Job Overview
Provide project related support and assistance for assigned projects and project teams by assisting in related procedures and performing tasks associated with the study lifecycle (start-up, maintenance, and closeout); Ensure work is conducted in line with standard operating procedures, policies and good practices.

Essential Functions
• Study and Activity Monitoring
a. Oversee and manage the timely closure of queries and work with the internal applicable teams or functional areas where applicable (examples may include, the Global Delivery Network, Contact Center or being the point of contact for client personnel to assist with service queries, including related to investigator reports).
b. Using monitoring tools, pro-actively identify trends and provide feedback to internal departments and/or client teams on performance of both the Investigator and the company services to ensure timely service delivery.  Examples may include:
   i. Monitor the performance of both the Investigator(s) and/or the Laboratory as applicable.
   ii. Monitor study specific and/or client requested requirements.
   iii. Oversee and/or monitor demographic queries, pending results, testing TAT’s, etc.
   iv. Oversee and ensure resolution of data discrepancies at all stages of the study.
   v. Ensure that queries and actions are being routed to appropriate internal functions, such as re-supplies, and/or dry ice requests as applicable.
   vi. Assist with the tracking of storage specimens: receipt, retrieval and shipping as applicable.
c. Use knowledge of Protocol specific and routine tasks to ensure outputs are delivered in line with organizational standards, study requirements and client expectations.
d. Conduct tasks that support all phases of the study-specific activity, including but not limited to, providing input into the design of the monitoring plan, creating and/or monitoring reports and metrics, and completion of protocol-specific materials as needed (e.g. laboratory manuals/guides, flow charts, etc.) as applicable.
e. Oversee and assist with the day-to-day running of designated projects, including patient specimen management receipt, pending lab analyses, and test result approvals and reports, and other duties as detailed in the project-specific monitoring plan.
• Provide Support to Project Manager
a. Perform generic, routine study duties and tasks that are applicable across designated projects and Protocol phases, including but not limited to:  receipt of site lists, entering site data into the database, flowcharts, ordering laboratory kits, and monitoring the day to day running of designated projects (i.e. patient specimen management receipt, pending lab analysis, and test result approvals and reports).
b. Provide regular Project Status reports to the Project manager, CRA, Sponsor and the company as applicable.
c. Support the Project Manager with the administrational tasks of the study (e.g. action item tracking, meeting minutes, change logs, etc.).
d. Act as backup support for the Project Manager during their times of absence, including leading client communication and management study activities.
e. Assist with document quality control review if applicable, including providing feedback comments and changes to Project Managers.
f. Coordinate and communicate with relevant stakeholders as instructed by the study Project Manager.
• Proactive lines of Communications
a. Interact with other functional areas and/or vendors to resolve problems, enhance processes and service delivery.
b. Liaise with other departments and support services (e.g. Logistics Department, courier services) in order to expedite the transportation of patients’ laboratory specimens.
c. Work closely with other members of the Global Project team, identifying issues that may impact the study, take action and/or make recommendations to improve processes and timelines for study completion.
d. Coordinate information and communications for designated projects at the site level, including identification and escalation of discrepancies as needed.
e. Liaise with study Sponsor as required.
f. Lead internal or external client calls, discussions and/or tasks for regional studies as required.
• Project Documentation and Deliverables
a. Support maintenance of project documentation files.
b. Support maintenance of internal databases with generic project information and input project specific information, as directed and if applicable.
c. Contribute to the development of meeting and training materials (e.g. Investigator Meeting presentations, Infosario training, etc.).
• Investigator Training and Meetings
a. If needed, represent the company at Investigator/ Monitor meetings and/or client meetings.
b. Administer study training to sites, CRA and/or sponsors as applicable.
c. Conduct Kick-Off/Project Launch meetings or other meetings on behalf of the Project Manager as needed.
d. Develop meeting and training materials as needed (e.g. Investigator Meeting, portal training, etc.).
• Process Improvements and Special Assignments
a. Develop and present information effectively to internal & external audiences, such as lessons learned, audits and sharing best practices (e.g. department training).
b. Participate in external and internal audits as needed.
c. Mentor and assist in training of more junior staff, including Project Coordinators.
d. May perform Sample Management activity oversight and monitoring, including assisting with the management of vendors where applicable.
e. May lead regional or validation studies under guidance from the line manager or mentor.
f. Lead Project Close-out procedures as required.
g. Perform other administrative or process-related duties as needed to support the success of the trial.
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

Qualifications
• High School Diploma or equivalent  Req
• Bachelor's Degree Life sciences
• 5 years’ relevant experience Req Or
• Equivalent combination of education, training and experience Req
• 1 year relevant experience in the Clinical, Medical or Healthcare industry Pref
• Strong interpersonal, communication, organizational, and time management skills,
• Must be able to comply with all applicable standards as required by the company.
• Demonstrated ability to handle multiple competing priorities; utilize resources effectively.
• 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.
• Computer proficiency in word processing and spreadsheet applications.
• Demonstrated ability to work in a fast-paced environment highly desirable.
• Ability to establish and maintain effective working relationships with coworkers and managers.
• Ability to manage regional or small global studies.
• Demonstrated ability to handle multiple competing priorities and utilize resources effectively.
• Demonstrated critical thinking and problem solving skills.
• Computer proficiency in word processing, presentation, and spreadsheet applications, including proficiency in Microsoft Project, Excel, Word and PowerPoint.