Regional Lead Site Coordinator

About the role

The Lead Site/Study Coordinator supports an assigned group of medical institutions for activities involving clinical trial conduct. They act as a constant line of communication between the assigned Milestone One Manager, the medical institution staff and administrators and the Sponsor or CRO. They also facilitate the evaluation of proposed studies and ensure responses to feasibility questions are provided in due time. They assist 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.

Responsibilities

• 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’s.
• 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.
• Supports proper handling, accountability, and reconciliation of all investigational products and clinical supplies.
• Supports the contract and budget negotiations and oversees Investigator/Site Payments. Develop new mechanisms that may reduce costs for Milestone One and/or increase revenue for our site partners.
• Ensures 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 protocol before site implementation as needed.
• 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.

Qualifications

• Education: University degree in life science, pharmacy, nursing, lab analytics or related (Master’s degree preferred).
• Certifications: Current Good Clinical Practice (GCP), International Air Transport Association (IATA), Current Basic Cardiopulmonary Resuscitation (CPR), Phlebotomy certification unless part of active professional licensure (RN or LPN), Active Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization.
• Experience: Displays leadership skills and proven ability to manage and provide training to a diverse team; effective communication techniques routinely displayed; Proficient in topics regarding GCP and IRB/Regulatory standards; familiarity with multi-therapeutic indications. Skills to be a mentor to Milestone One staff and perform as a liaison to a variety of site partners; Actively assist in maintaining relationships and developing new site partnerships.
• Knowledge & Skills: Must demonstrate proficiency in patient assessments, including triage, medication reconciliation, vitals, EKG, and lab processing; Excellent understanding of multi-therapeutic protocol design and how to reference requirements; Attention to detail and the ability to interpret and implement protocol and guidelines efficiently; Proficient in patient enrollment, management, and retention; Proficiency in Microsoft Office; Proficiency in most EDC/EMR vendor systems; Exceptional organizational and time-management skills.
• Additional Skills: Excellent communications skills; Fluent use of the local language; Valid category B driver’s license; Adequate personality traits that allow the candidate to function in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously. The candidate must be an effective communicator in stressful situations and have a “ready to solve problems” attitude.