Milestone One · 3 months ago
Regional Lead Site Coordinator (Northeast and West Coast Regions)
Northeast, WV
Full-time
Onsite
Senior LevelMilestone One is a fast-growing Site Enabling Organization operating globally in the field of clinical research. They are seeking a passionate and dedicated Lead Site Coordinator to support medical institutions with clinical trial conduct, ensuring compliance with protocols and facilitating communication between various stakeholders.
Research
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
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 and 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 protocol 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
Qualification
Required
University degree in life science, pharmacy, nursing, lab analytics or related
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
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
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
Proficient in most EDC/EMR vendor systems
Exceptional organizational and time-management 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
Non-standard working hours may be required depending on the schedule of study procedures and/or patient visits
Limited travel may be required for sponsor / CRO-initiated training
Preferred
Master's degree preferred
Benefits
Hybrid position (remote and on-site visits across different sites).
Company
Milestone One
Running clinical trials feels insurmountable for the average hospital, clinic, or practice.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase