Job Description: Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.
DescriptionThe Project Coordinator provides support to the Project Manager and related team members by performing generic procedures and tasks associated with the day to day running of projects throughout the entire study lifecycle (e.g. startup, maintenance and close-out); Ensure work is conducted in line with standard operating procedures, policies and good practices.
Study and Activity Monitoring
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).
Using monitoring tools, pro-actively identify trends and provide feedback to internal departments and/or client on performance of both the Investigator and the Q2 Solutions services to ensure timely service delivery. Examples may include:
Monitor the performance of both the Investigator(s) and/or the Laboratory as applicable.
Monitor study specific and/or client requested requirements.
Oversee and/or monitor demographic queries, pending results, testing TAT's, etc.
Oversee and ensure resolution of data discrepancies at all stages of the study.
Ensure that queries and actions are being routed to appropriate internal functions, such as (but not limited to) re-supplies, and/or dry ice requests as applicable.
Assist with the organization and tracking of storage specimens: receipt, retrieval and shipping as applicable.
Ensure outputs are delivered in line with organizational standards, protocol specific requirements and client expectations.
Provide Support to Project Manager
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).
Provide regular Project Status reports to the Project manager, CRA, Sponsor and/or Q2 Solutions as applicable.
Support the Project Manager with the administrative tasks of the study (e.g. action item tracking, meeting minutes, change logs, etc.).
Act as a backup support for the Project Manager during their times of absence, including leading client communication and management study activities.
Keep Project Managers and other relevant staff informed of any issues that may affect the smooth running of the project.
Coordinate and communicate with relevant stakeholders as instructed by the study specific team.
Proactive lines of communication
Interact with other functional areas and/or vendors to resolve problems, enhance processes and service delivery.
Liaise with other departments and support services (e.g. Laboratory) in order to expedite testing of patient's laboratory specimens and/or provision of kits.
Work through Protocol questions, issues, escalations and changes with relevant project team members. May have routine or ad-hoc contact with study Sponsor(s), e.g. exchanging factual information, etc.
Coordinate information and communications for designated projects at the site level, including identification and escalation of discrepancies as needed.
Assist with the development of meeting or training materials where applicable.
Project Documentation and Deliverables
Support maintenance of project documentation files.
Support maintenance of internal databases with generic project information and input project specific information, as directed and if applicable.
Process Improvements and Special Assignments
Develop solutions for routine project related issues and problems, within a limited scope.
Participate in local and global improvement projects as needed.
Participate in internal audits, as required.
Oversee and/or lead Project Close-out procedures as required.
Assist with the development of meeting or training materials where applicable
Perform other administrative or process-related duties as needed to support the success of the trial.
Job Requirements REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Strong customer-focus perspective with skill to guide customer communications and customer management.
Self-driven; keen attention to detail to anticipate, address and/or escalate issues, with aptitude to embrace and be conduit for change.
Project and task management capabilities to meet/exceed deliverables.
Effective problem solving skills as well as ability to proactively identifying process improvements which reduce operational costs and maintain quality.
Quality conscious with high degree of ethics and integrity carrying out duties in accordance to laws, regulatory standards, and with company policies and procedures.
Computer proficiency including word processing, and spreadsheet applications.
Ability to work independently and in collaboration with others
Ability to seek and receive constructive feedback
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree received in the last 24 months in project management, life science or related field with a minimum GPA of 3.2 from an accredited University or College.
Demonstrated leadership, such as leading a major event, a group, or on the job experience
Extensive use of telephone, computer aided, and face-to-face communication requiring accurate perception of speech and clear articulation and idea formation.
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time.
EEO Minorities/Females/Protected Veterans/Disabled
Job ID: 1808120
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