The Lead Site/Study Coordinator supports an assigned group of medical institutions for activities involving clinical trial conduct. Support for staff on protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Supervise tasks assigned to site level staff may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits, general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, back up site/study coordinator duties, compliance monitoring, mentoring Milestone One and site staff as well as development and administration of protocol specific tools and development and maintenance of Milestone One training program and administrative tasks as assigned by the Milestone One Manager.
The Lead Site/Study Coordinator:
- Acts as a constant line of communication between the assigned Milestone One Manager, the medical institution staff and administrators and the Sponsor or CRO.
- Acts as a liaison recruiting new site partners
- Acts as a resource for identifying new vendors for activities that cannot be provided by the medical institution.
- Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time.
- Assists with identifying new projects within the interests of the medical institution and/or areas in which there is a medical need to better serve the needs of Milestone One and the clinical site partner.
- Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria.
- Performs site quality checks to confirm compliance with the protocols and Milestone One SOP鈥檚.
- Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff.
- Evaluates protocols and develops recruitment strategies to enhance enrollment.
- Provides training to Milestone One and site staff regarding clinical research best practices and study specific processes.
- Participates in the development and deployment of the Milestone Site/Study Coordinator Training Program.
- Assists the local research team in standard clinical research procedures and tasks developing a site plan to efficiently incorporate clinical trials into the investigative site clinical practice with minimal interruption.
- Assists in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution as needed.
- Tracks patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments as needed.
- Ensure accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions as needed.
- Supports proper handling, accountability, and reconciliation of all investigational products and clinical supplies.
- Supports the contract and budget negotiations鈥痑nd oversees Investigator/Site Payments. Develop new mechanisms that may reduce costs for Milestone One and/or increase revenue for our site partners.
- Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the鈥痯rotocol before site implementation as needed.
- Actively participates in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections as needed. Performs a site readiness inspection prior to any sponsor/CRO or regulatory inspections.
- Assisting with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs) as needed.
- Regularly involved in the on-site training of additional staff as part of the SEO or other education programs.
- Assists with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements that can be implemented for all Milestone One site partners.
- Maintains all licensure and certifications applicable to the role of Lead Site/Study Coordinator.
- Maintains familiarity with all protocols being conducted at sites within the assigned region and act as a reliable resource for Milestone One and site staff.
- Lead Site/Study Coordinator is responsible for only performing assigned tasks within their training and licensure if applicable.
Reporting Line:
The Lead Site/Study Coordinator reports administratively to the Milestone One Manager responsible for the region. Within clinical trials, the Lead Site/Study Coordinator reports to the individual Principal Investigators by the responsibilities as delegated on the delegation of authority log for each clinical trial as required to provide back-up site/study coordinator support to site staff. The Lead Site/Study Coordinator is responsible for providing services as assigned and should consult the Milestone One Manager assigned for any questions.