Project Coordinator II (Argentina)

Reposted 14 Days Ago
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Hiring Remotely in Argentina
Remote
Junior
Pharmaceutical • Manufacturing
The Role
The Project Coordinator II manages site activation and maintenance for clinical studies, ensuring timely documentation, communication, and compliance with regulations.
Summary Generated by Built In
Description

PLEASE SUBMIT YOUR RESUME IN ENGLISH

The Project Coordinator II provides coordination and operational support for site activation and maintenance activities across all study phases. This role demonstrates greater autonomy and ownership, with accountability for assigned projects and deliverables. The PC II ensures timely and accurate completion of site-level and project documentation, proactive communication, and compliance with study timelines.

This role is perfect for you if:

  • You have an experience in project administration and clinical research;
  • You want to work in a collaborative environment;
  • You want to have an impact in a fast-growing company.

RESPONSIBILITIES

More specifically, the Project Coordinator:

  • Lead assigned site activation activities, ensuring delivery within established timelines and quality standards.
  • Coordinate, collect, review, and approve essential regulatory and clinical trial documents from investigator sites.
  • Act as the primary point of contact for assigned sites on operational and administrative matters.
  • Communicate effectively with internal teams (e.g., Clinical Operations, Regulatory, Data Management) to align priorities and address issues impacting activation or maintenance.
  • Identify potential risks or delays in site activation and escalate to the Project Manager as appropriate.
  • Ensure that essential documents are accurate, complete, and compliant for first-pass review and site activation.
  • Maintain up-to-date information in the CTMS, eTMF, and other tracking tools.
  • Prepare meeting minutes, study trackers, and reports for internal and client updates.
  • Support ethics committee submissions and country-specific regulatory requirements when applicable.
  • Coordinate training assignments and maintain documentation for project-specific training activities.
  • Prepare and distribute study correspondence, site communications, and tracking documentation.
  • Manage logistics related to investigator meetings, study supplies, and ISF distribution.
  • Participate in audits and inspections, providing relevant documentation and supporting responses to findings.
  • Contribute to process improvements, best practice documentation, and SOP compliance initiatives within the Project Coordination team.
  • Provide guidance to junior coordinators on standard processes and administrative activities
Requirements

IDEAL PROFILE

  • Bachelor’s degree in a field relevant to clinical research or equivalent experience.
  • 1 to 2 years of experience in clinical research, preferably in a CRO, biotech, or pharmaceutical setting.
  • Sound understanding of GCP, ICH guidelines, and clinical documentation standards.
  • Strong interpersonal and organizational skills, with the ability to prioritize and manage multiple tasks.
  • Excellent written and verbal communication skills in English; bilingualism an asset.
  • Demonstrated ability to work independently and collaboratively within cross-functional teams.
  • Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
Our company

The work environment 


At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 


In this position, you will be eligible for the following perks: 

  • Flexible work schedule / work schedule :
  • Home-based position
  • Ongoing learning and development 

About Indero

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale..


Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 

Indero only accepts applicants who can legally work in Argentina


Skills Required

  • Bachelor's degree in a field relevant to clinical research or equivalent experience
  • 1 to 2 years of experience in clinical research
  • Understanding of GCP, ICH guidelines, and clinical documentation standards
  • Strong interpersonal and organizational skills
  • Excellent communication skills in English
  • Ability to work independently and in teams
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The Company
Montreal, , Quebec
377 Employees
Year Founded: 2000

What We Do

As a CRO (Contract Research Organization) specialized in dermatology and rheumatology, we provide scientific guidance, accurate results and customer satisfaction. Our unique service offering combines specialized Contract Research Services, knowledge of dermatology sites in North America and Europe reach and the extended capabilities of a large clinical research site. The design and conduct of Phase I to Phase IV studies is our core expertise. Our specialized services include: • Study Design and Protocol Development • Submission to Regulatory Agencies and Central Ethics Committees • Regulatory Consulting • Trial Master Files Management • Project Management • Investigator / Site Selection • Patient Recruitment • Clinical Monitoring • Medical Monitoring • Pharmacovigilance • Data Management • Biostatistical Analysis • Clinical Study Report • Medical Writing / Publication Since 2000, Innovaderm has built a strong reputation for the quality of its research and the care offered to its study participants, its clients and its sites, often exceeding our client’s timeline expectations.

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