Regional Lead Site Coordinator for South-East Region
Milestone One · United States · 2 wk ago
RemoteRemoteAdministrativeFull-time
About the role
The Lead Site 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.
Responsibilities
- Supervising tasks assigned to site-level staff.
- Supporting feasibility assessments for new and potential clinical studies.
- Conducting research-related visits according to study protocols.
- Coordinating research visit logistics, scheduling, and patient flow.
- Collaborating with ancillary departments involved in research activities.
- Assisting with general study conduct and data entry into EDC systems.
- Coordinating monitoring visits with CRO and sponsor representatives and resolving study-related issues.
- Providing backup Site/Study Coordinator support when needed.
- Monitoring compliance with GCP and regulatory requirements.
- Mentoring Milestone One and site staff.
- Developing protocol-specific tools and training materials.
- Supporting the development and maintenance of Milestone One's training program.
- Performing additional administrative responsibilities as assigned by the Milestone One Manager.
Requirements
- University degree in Life Sciences, Pharmacy, Nursing, Laboratory Analytics, or a related field (Master's degree preferred).
- Current Good Clinical Practice (GCP) certification.
- International Air Transport Association (IATA) certification.
- Current Basic Cardiopulmonary Resuscitation (CPR).
- Phlebotomy certification (unless included within an active RN or LPN license).
- Active Clinical Research Certification (ACRP, SOCRA, or another approved Clinical Research Organization).
Qualifications
- Demonstrated leadership skills with experience managing and training diverse teams.
- Strong communication and interpersonal skills.
- Thorough understanding of GCP and IRB/Regulatory requirements.
- Experience across multiple therapeutic areas.
- Ability to mentor colleagues and build strong relationships with clinical sites.
- Experience developing and maintaining site partnerships.
Schedule
This is a hybrid position, combining remote work with on-site visits across different research sites.
Benefits
- Join a growing global organization where your expertise will make a real impact.
- Work alongside dedicated professionals and contribute to meaningful clinical research.
- Opportunities to grow your career in an environment that values collaboration, quality, and continuous development.