Senior Clinical Site Coordinator

Milestone One; La Plata; Híbrido; ARS 1.200.000 - 2.000.000; Jornada completa

Descripción de la vacante

Milestone One is seeking a Senior Clinical Site Coordinator to lead site readiness, activation, and day‑to‑day coordination of trials in Argentina. You will work with investigators, hospital departments, CRAs, CTMs, and vendors, operating within delegated activities to establish operational processes at sites.

The role emphasizes autonomy, international trial experience, and strong ICH-GCP knowledge, with hybrid/field work and potential regional travel.

Formación

• University degree in life sciences or related field.
• 3–5 years of direct clinical research experience.
• Experience as Site Coordinator or Senior Site Coordinator.
• Experience in international Phase II or Phase III trials.
• Site start‑up and activation experience (preferred).
• Experience with complex protocols involving labs, e‑diaries, investigational product, PK sampling, or home-based activities (preferred).
• Public hospitals or institutions where clinical research processes are developing (preferred).
• Strong knowledge of ICH-GCP and investigator-site responsibilities.
• Fluent English at least B2 level.
• Proficiency in MS Office and valid driver’s license.

Responsabilidades

• Conduct protocol-specific site readiness and gap assessments.
• Support preparation for Site Initiation Visits (SIV), site activation, and first-patient readiness.
• Coordinate workflows involving investigators, labs, pharmacy, imaging, pathology, and vendors.
• Coordinate recruitment activities and pre-screening documentation.
• Prepare participant visit plans and track protocol windows, samples, and follow‑ups.
• Coordinate complex workflows including monitoring periods and home-based activities.
• Maintain essential documents, training records, and study trackers.
• Support source documentation and eCOA/e‑diary follow‑ups when delegated.
• Prepare sites for monitoring visits and ensure timely closure of follow‑ups.
• Identify operational, quality, recruitment, or safety risks early.
• Help establish scalable clinical research processes across sites.

Conocimientos

ICH-GCP knowledge

Stakeholder management

Organizational skills

Fluent English (B2)

MS Office proficiency

Educación

University degree in life science or related

Herramientas

EDC

MS Office

Descripción del empleo

Milestone One is a Site Enabling Organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need, and our mission is to strengthen study delivery by connecting sponsors, CROs, and medical institutions through strategic partnerships that accelerate clinical research.

Job Description

The Milestone One Senior Clinical Site Coordinator is a key member of the Operations team, taking hands‑on responsibility for the preparation, activation, and day‑to‑day coordination of clinical trial activities at Milestone One-supported investigator sites in Argentina, initially focusing on strategically important sites.

We are looking for an experienced and autonomous Senior Clinical Site Coordinator who can work directly with investigators, hospital departments, CRAs, CTMs, and study vendors without close day‑to‑day supervision. This role requires the ability to establish operational processes in sites where the clinical research structure may still be developing, while operating strictly within formally delegated and authorized activities.

In this role you will:

• Conduct protocol-specific site readiness and gap assessments to support successful study initiation.
• Support preparation for Site Initiation Visits (SIV), site activation, and first-patient readiness.
• Map and coordinate protocol-specific workflows involving investigators, laboratory, pharmacy, imaging, pathology, sample logistics, study vendors, and other institutional departments.
• Coordinate recruitment activities, referral pathways, pre‑screening documentation, and candidate follow‑up.
• Prepare participant‑specific visit plans and track protocol windows, procedures, samples, results, and follow‑up actions.
• Coordinate complex and protocol‑critical workflows, which may include prolonged screening periods, extensive eligibility documentation, participant diaries, time‑sensitive sample collection, home‑based procedures, investigational product logistics, and safety follow‑up.
• Maintain essential documents, training records, action logs, and study trackers.
• Support source documentation, EDC entry, query resolution, and eCOA/e‑diary follow‑up when formally delegated, trained, and authorized.
• Prepare sites for monitoring visits and ensure timely closure of follow‑up items.
• Identify and elevate operational, quality, recruitment, safety‑routing, or resource risks early.
• Help establish reliable and scalable clinical research processes across supported institutions.

Qualifications

Education:

University degree in life science, pharmacy, nursing, lab analytics or related

Experience:

• Minimum 3 -5 years of direct clinical research experience in a clinical environment.
• Previous experience working independently as a Site Coordinator or Senior Site Coordinator.
• Experience in international Phase II or Phase III clinical trials.
• Study start‑up and activation experience (preferred)
• Complex protocols involving central laboratories, e‑diaries, investigational product, PK sampling, external vendors, or home‑based activities (preferred)
• Public hospitals or institutions where clinical research processes are still being developed (preferred)
• Recruitment strategies and referral‑network coordination (preferred)
• Mentoring junior coordinators or institutional staff (preferred)

Knowledge & Skills:

• Strong knowledge of ICH-GCP and investigator-site responsibilities.
• Experience with EDC and other clinical trial systems.
• Strong organizational, documentation, and stakeholder‑management skills.
• Ability to coordinate complex protocols and work with urgency without compromising accuracy.
• Fluent use of local language, at least B2 level of English
• Proficiency in MS Office
• Valid category B driver’s license

Additional Information

Hybrid and field‑based. The candidate may be based in Buenos Aires City, Greater Buenos Aires, La Plata, or the surrounding area. On‑site presence will be required according to site‑and study‑specific operational needs, particularly during site setup, activation, screening, participant visits, monitoring activities, and other protocol‑critical periods. Remote work may be possible when activities do not require physical presence at the institution.

Type of Contract: B2B

Development Opportunities: A strong performer may progressively assume broader Lead Site Coordinator responsibilities and support additional institutions as the Milestone One network in the Buenos Aires region expands.