Clinical Data Coordinator
Quotient Sciences
23 hours ago
Full-time
On-site
Miami, Florida, United States
Speech-Language Pathologist
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 , improves outcomes, and significantly accelerates 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
Responsible for the following data entry associated tasks for their assigned studies: source document retrieval, source data QC, data entry, source document filing, QC of CRF entries, laboratory result tracking, and archiving
To comply & adhere to GCP guidelines and regulations as required of this role.
To provide support to the Clinic and PM teams
Main Tasks and Responsibilities
Prepares study binders for source document storage as instructed by Project Management
Supports and performs QC of all source documents, paper and electronic
Identifies discrepancies in source documents and works with clinical staff for corrections or explanations
Evaluates query responses in eSource. May reissue query as necessary
Enters subject data from source documents into client databases in accordance with the eCRF completion guidelines/Data Management Plan and study timelines
Resolves or escalates queries within the established timelines
Identifies source document or EDC database issues and promptly communicates them to the Project Management team
Enters, tracks, and performs QC for Adverse Events and Concomitant Medications
Performs Adverse Event and Concomitant Medication Count (source vs. eCRF).
Performs QC for 100% of completed CRF entries
Performs timely lab result tracking
Responsible for the accurate and timely filing of all study-related documents
Ensures that volunteer source document files/binders are ready for monitoring visits
Provides supervisor a daily update of status for all data entry associated tasks for assigned studies
Maintains record of entry/QC in tracker spreadsheet
Reports protocol deviations promptly
Archives completed study documents according to established SOPs and Work Instructions
Accounts for unscheduled lab reports and performs QC/QA for lab data transfer files as assigned by Project Management
Assists with all other duties as assigned
Acts as recorder for clinical activities in eSource as required
Supports clinical and PM staff as assigned
Job Demands
The job may involve the following:
Very high concentration of work
Strict and tight deadlines
Having to juggle a range of tasks/issues simultaneously
Working in a hazardous environment with high requirement to follow safety procedures
Working outside normal working hours
Needing to respond to client demands
The Candidate
Effective communication skills
Computer proficiency (Microsoft Word, Excel and Office Suite products)
High School Diploma or equivalent
Data input and/or QC review experience
Able to assume increasing levels of responsibility and perform effectively
Able to plan, coordinate, organize, and prioritize to meet deadlines
Able to interact successfully with team members and study participants
Self-directed - able to perform with minimal supervision
Thorough in task completion- attention to detail
Able to read and understand protocols
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.
Our Approach to AI in Recruitment
At Quotient Sciences, we use technology, including AI-enabled tools, to support parts of our recruitment process and help create an efficient, consistent, and inclusive candidate experience. Any use of AI is subject to human oversight, and hiring decisions are made by people, not technology.
While we embrace innovation, our recruitment process remains deeply human. Candidates who progress through our recruitment process are supported by a dedicated recruitment contact, and many of our selection processes include in-person interviews. We believe the best hiring decisions come from real conversations, giving candidates the opportunity to meet future colleagues, experience our culture and showcase their strengths beyond their application.
We recognize that candidates may choose to use AI tools when preparing applications. We encourage the responsible use of technology to support research, preparation, and drafting. However, applications should reflect your own skills, experiences, and perspectives. Throughout the recruitment process, we assess authenticity, critical thinking, technical capability, and the unique contribution you can bring to Quotient Sciences. Content generated entirely by AI may not provide an accurate representation of your suitability for the role.
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 , improves outcomes, and significantly accelerates 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
Responsible for the following data entry associated tasks for their assigned studies: source document retrieval, source data QC, data entry, source document filing, QC of CRF entries, laboratory result tracking, and archiving
To comply & adhere to GCP guidelines and regulations as required of this role.
To provide support to the Clinic and PM teams
Main Tasks and Responsibilities
Prepares study binders for source document storage as instructed by Project Management
Supports and performs QC of all source documents, paper and electronic
Identifies discrepancies in source documents and works with clinical staff for corrections or explanations
Evaluates query responses in eSource. May reissue query as necessary
Enters subject data from source documents into client databases in accordance with the eCRF completion guidelines/Data Management Plan and study timelines
Resolves or escalates queries within the established timelines
Identifies source document or EDC database issues and promptly communicates them to the Project Management team
Enters, tracks, and performs QC for Adverse Events and Concomitant Medications
Performs Adverse Event and Concomitant Medication Count (source vs. eCRF).
Performs QC for 100% of completed CRF entries
Performs timely lab result tracking
Responsible for the accurate and timely filing of all study-related documents
Ensures that volunteer source document files/binders are ready for monitoring visits
Provides supervisor a daily update of status for all data entry associated tasks for assigned studies
Maintains record of entry/QC in tracker spreadsheet
Reports protocol deviations promptly
Archives completed study documents according to established SOPs and Work Instructions
Accounts for unscheduled lab reports and performs QC/QA for lab data transfer files as assigned by Project Management
Assists with all other duties as assigned
Acts as recorder for clinical activities in eSource as required
Supports clinical and PM staff as assigned
Job Demands
The job may involve the following:
Very high concentration of work
Strict and tight deadlines
Having to juggle a range of tasks/issues simultaneously
Working in a hazardous environment with high requirement to follow safety procedures
Working outside normal working hours
Needing to respond to client demands
The Candidate
Effective communication skills
Computer proficiency (Microsoft Word, Excel and Office Suite products)
High School Diploma or equivalent
Data input and/or QC review experience
Able to assume increasing levels of responsibility and perform effectively
Able to plan, coordinate, organize, and prioritize to meet deadlines
Able to interact successfully with team members and study participants
Self-directed - able to perform with minimal supervision
Thorough in task completion- attention to detail
Able to read and understand protocols
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.
Our Approach to AI in Recruitment
At Quotient Sciences, we use technology, including AI-enabled tools, to support parts of our recruitment process and help create an efficient, consistent, and inclusive candidate experience. Any use of AI is subject to human oversight, and hiring decisions are made by people, not technology.
While we embrace innovation, our recruitment process remains deeply human. Candidates who progress through our recruitment process are supported by a dedicated recruitment contact, and many of our selection processes include in-person interviews. We believe the best hiring decisions come from real conversations, giving candidates the opportunity to meet future colleagues, experience our culture and showcase their strengths beyond their application.
We recognize that candidates may choose to use AI tools when preparing applications. We encourage the responsible use of technology to support research, preparation, and drafting. However, applications should reflect your own skills, experiences, and perspectives. Throughout the recruitment process, we assess authenticity, critical thinking, technical capability, and the unique contribution you can bring to Quotient Sciences. Content generated entirely by AI may not provide an accurate representation of your suitability for the role.