Clinical Trial Operations Coordinator

Quotient Sciences; Miami (FL); On-site; USD 52,000 - 76,000; Full time

Job summary

Quotient Sciences in Miami, FL is seeking a detail-oriented clinical operations support professional to assist in the production and management of study documentation, vendor setup, and regulatory submissions.

You will participate in risk-based monitoring, data generation tasks, and coordination across cross-functional teams, with on-site collaboration and a focus on quality and compliance.

Qualifications

• Minimum Degree qualification or equivalent.
• Experience in a pharmaceutical company/CRO would be an advantage.
• Experience with electronic Veeva Trial Master Files preferred.
• Highly organized and efficient.
• Ability to communicate effectively; people-oriented personality.

Responsibilities

• Assist in production and formatting of study documentation e.g. informed consent forms, training materials, file notes, laboratory manuals etc.
• Support set up of vendors.
• Internal risk-based monitoring following first dosing to ensure all study documentation is working effectively.
• Assist with internal data generation such as recruitment and subject status updates, adverse event summaries etc.
• Support study review board submissions by uploading administrative documents, study updates, and required correspondence.
• Process Spanish regulatory documents and communicate approvals to the teams.
• Set up and host Sponsor monitoring visits
• CRA Trial One Training
• CRA Veeva e-TMF Training
• Ensure monitoring visit action items are addressed
• Assist Project Managers with close out activities e.g. archiving, reconciliation.
• Ongoing clinic query resolution from screening through post discharge following SDV.
• Manage laboratory requisitions and collaborate with Data Management to support query resolution.
• Action process improvement initiatives as allocated
• Work with the study team to ensure the Investigator Site File and Trial Master Files are maintained and perform periodic QC of TMF (as per DOC-00433 Trial Master File).
• General support to the Commercial and Project Management groups as needed to win and deliver business
• Support PM Team on PSA set up and invoicing.
• Participate in an on-call rotation to provide coverage for clinical dose supervision activities, ensuring subject safety, protocol compliance, and operational continuity outside of standard business hours.
• Support Database close and lock activities.
• Support SBIM (meeting minutes).
• Support Trial One UAT activities.
• This is an on-site position based in the Miami, FL office.
• Regular on-site presence is required to support clinical trial operations and collaboration with cross-functional teams.

Skills

Organized

Communication skills

People-oriented

Education

Bachelor's degree or equivalent

Job description

Quotient Sciences in Miami, FL is seeking a detail-oriented clinical operations support professional to assist in the production and management of study documentation, vendor setup, and regulatory submissions.

You will participate in risk-based monitoring, data generation tasks, and coordination across cross-functional teams, with on-site collaboration and a focus on quality and compliance.