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ProPharma · 2 months ago

On-site Central Study Coordinator/Research Assistant - Argentina

United States

Full-time

Onsite

Entry, Mid Level

1+ years exp

ProPharma is a consulting firm that has been enhancing patient health and wellness for over 20 years by supporting biotech, med device, and pharmaceutical organizations. The Central Study Coordinator/Research Assistant will be responsible for coordinating and supporting remote site activities for assigned projects, ensuring effective communication and compliance with regulatory standards.

BiopharmaMedicalPharmaceutical

Responsibilities

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

Qualification

Study Coordinator experienceICH/GCPCritical thinking skillsCommunication skillsMultitaskTechnology managementWork independentlyTeam collaboration

Required

Ability to manage technology and web-based research platforms on PC (Microsoft OS) laptop in the remote workspace

Study Team 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

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

Minimum 2 years of study coordinator experience

Bachelor's degree or equivalent experience defined as a minimum of 1 year related, combined experience in education, knowledge and skills that will allow one to perform the tasks of the role proficiently