Milestone One ยท 6 hours ago
Clinical Study Coordinator/Site Coordinator
Rio Grande City, TX
Full-time
Onsite
Entry, Mid Level
2+ years expMilestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland, dedicated to supporting clinical study sites in stronger study delivery. The Site/Study Coordinator will assist in clinical trial-related activities, ensuring compliance with protocols and regulations while facilitating communication between stakeholders and supporting patient recruitment and data management.
Pharmaceuticals
Responsibilities
Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution
Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time
Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria
Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff
Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed
Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or would prohibit or delay study treatment
Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual
Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution
Track 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
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
Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding
Assist site staff with maintaining appropriate temperature monitoring for study products and supplies
Support the contract and budget negotiations and oversees Investigator/Site Payments
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
Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc
Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections
Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs)
May be involved in the on-site training of additional staff as part of the SEO or other education programs
Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements
Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II
SEO SC is responsible for only performing assigned tasks within their training and licensure if applicable. SEO SC should immediately consult the assigned Milestone One manager for tasks that do not fall within their scope
Qualification
Required
Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects
Bilingual proficiency in English and Spanish is required
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)
Preferred
Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified
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