Job Overview
Employment Type
Full-time
Compensation
Type:
Hourly
Rate:
Range $21.00 - $34.50
Work Schedule
Standard Hours
Benefits
Health Insurance
Dental Insurance
Paid Time Off
Professional development opportunities
Retirement Plan
Employee wellness programs
On-site work environment
Job Description
Milestone One is a reputable Site Enabling Services organization with its global headquarters located in Zug, Switzerland. The company has established itself as a critical player in the clinical research sector by understanding the unique challenges and needs of clinical study sites. Milestone One's mission revolves around supporting medical institutions and research sites to enhance study delivery, ensuring that clinical trials are conducted efficiently, ethically, and within the regulatory framework. By providing tailored services and solutions, Milestone One helps streamline the complex process of clinical research, benefitting sponsors, CROs, and medical institutions alike.
Milestone One is currently seeking a dedicat... Show More
Milestone One is currently seeking a dedicat... Show More
Job Requirements
- Relevant education
- At least two years of experience coordinating clinical research studies involving human subjects
- Bilingual proficiency in English and Spanish
- Certification in Good Clinical Practice (GCP)
- Certification in International Air Transport Association (IATA)
- Certification in Basic Cardiopulmonary Resuscitation (CPR)
- Phlebotomy certification or active RN or LPN licensure
- Ability to maintain confidentiality and regulatory compliance
- Willingness to work on-site in Harlingen / Rio Grande Valley
Job Qualifications
- Relevant education and at least two years of experience coordinating clinical research studies involving human subjects
- Bilingual proficiency in English and Spanish
- Current Good Clinical Practice (GCP) certification
- International Air Transport Association (IATA) certification
- Current Basic Cardiopulmonary Resuscitation (CPR) certification
- Phlebotomy certification unless part of active professional licensure (RN or LPN)
- Preferred certification in Clinical Research by ACRP or SOCRA or another approved organization - may be obtained within one year of employment or status change if not currently certified
Job Duties
- Act as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution
- Facilitate the evaluation of proposed studies and ensure responses to feasibility questions are timely
- Actively participate in patient recruitment and evaluation for study inclusion according to inclusion and exclusion criteria
- Assist with development of recruitment and retention tools, source documentation, and other site tools to enhance quality and time management
- Assist the local research team in obtaining informed consent before study entry or any study procedures
- Obtain required assessments per protocol visits and notify investigators of critical values
- Assist with local and central laboratory testing, processing, and shipping per SOP and study-specific manuals
- Schedule and prepare for sponsor or CRO visits at the medical institution
- Track patient recruitment and support the medical site team to meet enrollment targets
- Ensure accurate and timely data entry into EDC systems and resolve data queries
- Support proper handling, accountability, and reconciliation of investigational products while maintaining study blinding
- Maintain temperature monitoring for study products and supplies
- Support contract and budget negotiations and oversee Investigator/Site Payments
- Ensure staff complete study-specific and general training prior to trial involvement
- Ensure investigators review and sign study documents appropriately
- Maintain study documents for on-site visits, audits, and regulatory inspections
- Assist with preparing and submitting regulatory documents to authorities and IRBs
- Participate in on-site training of additional staff and SEO education programs
- Identify areas for site improvement and develop tools to assist
- Maintain all licensure and certifications applicable to the SEO Site/Study Coordinator II role
- Perform only assigned tasks within training and licensure and consult Milestone One manager for tasks outside scope
Job Qualifications
Experience
Mid Level (3-7 years)
Job Location
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