Study Coordinator - Beunos Aires, Argentina

ProPharma Group; Buenos Aires; Híbrido; ARS 800.000 - 1.400.000; Jornada completa

Descripción de la vacante

ProPharma Group is seeking a Central Study Coordinator to support remote site activities for assigned projects and reside in or near Buenos Aires, Argentina.

You will act as the day-to-day contact for site communications, assist with screening and recruitment, obtain medical records, re-consent participants, and manage data-entry and database monitoring in line with ICH/GCP and regulatory standards.

Formación

• Bachelor's degree or equivalent experience.
• 2+ years related experience in clinical research or coordinating sites.
• Knowledge of ICH/GCP guidelines and regulatory requirements.
• Ability to work remotely with privacy and strong communication skills.
• Multitasking, organization and attention to detail essential.

Responsabilidades

• Serve as point of contact for day-to-day Site communications and document submissions.
• Support pre-screening, screening and recruitment activities.
• Coordinate subject re-consenting, medical records, and protocol activities.
• Perform data-entry and monitor databases; respond to system queries.
• Maintain timely site communications and documentation compliant with IRB/FDA policies.
• Assist with study closeout and other site-related tasks.

Conocimientos

Communication

Data entry

IRB/FDA compliance

ICH/GCP

SOPs

Documentation

Site coordination

Remote work

Educación

Bachelor's degree

Descripción del empleo

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.* The Central Study Coordinator position is responsible for the coordination and support of remote site activities for assigned projects and must reside in or near Buenos Aires, Argentina.**Essential Functions:*** Serve as point of contact for day-to-day Site communications, document submissions and activity coordination.* Support pre-screening, screening and recruitment activities, as assigned.* Responsible for subject re-consenting, acquiring medical records, conducting protocol activities, as directed by the Principal Investigator.* Perform data-entry, evaluate and respond to system queries and monitor clinical databases as assigned.* Establish and maintain timely Site communication as assigned.* Maintain documentation which complies with IRB/FDA policies.* Assist with study closeout.* Assist site with other study-related activities as directed.* Other duties as assigned.**Necessary Skills and Abilities:*** Ability to manage technology and web-based research platforms on PC (Microsoft OS) laptop in the remote workspace.* Study Tearn experience is ideal.* Critical thinking skills.* Strong communication Skills (verbal and written).* Ability to work independently, and collaboratively with other CSCs to delegate tasks as needed.* Working location that has the ability to maintain privacy.* Current knowledge of and the ability to apply ICH / GCP and applicable regulations and guidelines.* Competent in the application of standard business procedures including but not limited to SOPs, global regulations.* Well organized and able to multitask.* Able to work independently and as a team member.* Able to take initiative while following directives.**Educational Requirements:*** Bachelor's degree or equivalent experience defined as a minimum of 2 years related, combined experience in education, knowledge and skills that will allow one to perform the tasks of the role proficiently.#LI Remote