Clinical Project 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

Posted Wednesday, July 29, 2026 at 10:00 AM

Quotient Sciences: Molecule to Cure. Fast.
Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.

Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improve outcomes, and significantly accelerate drug development times.

Why join us:
Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.

The Role

• To support project management in the completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget
  To comply & adhere to GCP guidelines and regulations as required of this role

Main tasks and 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.

The Candidate

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

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.