Regional Lead Site Coordinator (South east region) at PSI CRO

, , United States -

Full Time

Start Date

Immediate

Expiry Date

14 Jan, 26

Salary

0.0

Posted On

16 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trials, Communication, Data Entry, Problem Solving, Regulatory Compliance, Patient Enrollment, Team Leadership, Monitoring Visits, Document Tracking, Adverse Events Reporting, Budget Negotiation, Relationship Building, Flexibility, MS Office Proficiency, CPR Certification, ICH GCP Training

Industry

Pharmaceutical Manufacturing

Description

Company Description Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery. Job Description Milestone One Site Coordinator supports trial sites in all related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals. In this role you will: Act as the main line of communication between the Sponsor or CRO and the site. Ensure response to feasibility questions are provided in due time. Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center. Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution. Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals. Maintain study specific and general tracking of documents at the site level. Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site. Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations. Proper handling, accountability and reconciliation of investigational products and clinical supplies. Collect, handle and maintain all site-specific regulatory documents as needed. Facilitate and support the contract and budget negotiations at the site level. Support Investigator and Site payments and processes as needed. Schedule and/or perform study procedures as per study requirements and delegation of responsibilities. Prepare for and participate in onsite study audits or regulatory agency inspections. Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions). Qualifications Academic Background/Certifications: University degree in life science, pharmacy, nursing, lab analytics or related (Master’s degree preferred) Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. ICH GCP training CPR certification IATA certification is an asset Experience: Minimum 4 years of on-the-job experience coordinating clinical trials on site. Experience leading teams or training new hires/site staff is preferred. Soft Skills: Ability to work in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously. Ability to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner. Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits. Other Requirements: Fluent use of the local language Proficiency in MS Office Valid Category B driver’s license Additional Information Hybrid position (remote and on-site visits across different sites). If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you.

Responsibilities

The Regional Lead Site Coordinator acts as the main line of communication between the Sponsor or CRO and the site, ensuring timely responses to feasibility questions and assisting in monitoring visits. They track patient enrollment and support the medical site in meeting project timelines and enrollment goals.