SUMMARY:

The Project Management Specialist’s (PMS) role is to support the successful performance and operations of Elligo’s clinical trials. The PMS serves as a liaison between multiple departments to ensure project tasks are tracked and/or completed. This position supports Elligo projects by coordinating collection and submission of all regulatory related documents, obtaining, and reviewing required medical records, data entry, and other various project support tasks. The PMS combines organizational skills, technical skills, and communication to complete project related tasks from study award to study closure.

ESSENTIAL DUTIES:

• Performs set-up, maintenance and close out project files and study information (e.g., regulatory documents, Investigator Site File (eISF), enrollment, protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on Elligo systems and client systems if applicable.
• Works within forecasted submission/approval timelines and ensures they are compiled with and tracks milestone progress in agreed upon system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plans to mitigate impact, and escalates the issues as soon as identified
• Prepares and completes the preparation of regulatory documents required for IRB/IBC approvals, development and maintenance of investigator essential regulatory documents, and coordination of ongoing research monitoring activities.
• Oversees ongoing submissions, amendments, and periodic notifications required by central IRB
• Assists with coordination of team meetings, attends meetings, and prepares accurate meeting minutes and action items for both internal and external meetings.
• Records the status of milestones and key performance indicators, with input and oversight from the assigned Project Manager (PM).
• Assesses and communicates key performance indicators for associated job tasks to PM with proposed action plan.
• Ensures all study documents are filed in eISF as required based on the appropriate guidelines and Policy and completes periodic reviews (including prior to monitoring visits and at the study closeout visit) of the eISF to ensure completeness and quality.
• Provides support for quality assurance activities, including preparation for audits and internal review, preparing documentation and following through to resolve actionable issues.
• Facilitates the timely and proper collection and management of medical records per scope of clinical trials.
• Maintains, updates, and inputs clinical tracking information into database as needed.
• Responsible for accurately maintaining study databases
• Performs other duties as required and/or assigned.

QUALIFICATIONS:

• Strong interpersonal skills and ability to build positive relationships
• Excellent verbal and written communication skills, including the ability to effectively convey ideas and information with clarity.
• Strong attention to detail and able to perform detailed tasks within condensed timelines.
• Strong organization/prioritization skills for the management of multiple concurrent projects and to ensure timely follow through.
• Thorough understanding of HIPAA privacy and security laws around PHI
• Ability to collaborate and work with cross functional groups/teams to effectively achieve business results.
• Self-motivated with the ability to work independently to complete tasks, respond to department requests, and collaborate with others to utilize their resources and knowledge to identify quality solutions.
• Skilled at effectively interacting and working with others, including peers, patients, management, and internal and external stakeholders.
• Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS Office products such as Excel and Word.
• Adaptable in a fast-paced environment with changing priorities, tasks, and client conditions.

EDUCATION AND EXPERIENCE:

• BS/BA in Life Science or related discipline.
• Minimum of one (1) year clinical research experience (including Study Coordinator, CRO experience) or working in a healthcare setting.
• Previous GCP training and certification is preferred.
• Experience working with electronic medical records (EMRs); electronic health record system proficiency is preferred
• Data entry experience is preferred