Provide 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.
location: Marietta, Georgia
job type: Permanent
salary: $60,000 - 70,000 per year
work hours: 9 to 5
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 company 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 the company 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.
Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice
Central Laboratory Experience/Familiarity
skills: Project Management
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.