Clinical Data Coordinator (Per Diem) jobs in United States
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Quotient Sciences · 3 days ago

Clinical Data Coordinator (Per Diem)

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. The Clinical Data Coordinator will be responsible for data entry tasks for assigned studies, ensuring compliance with GCP guidelines and providing support to the Clinic and Project Management teams.

Clinical TrialsCommercialConsultingHealth CareManufacturingMedicalPharmaceutical
Hiring Manager
Katrina Simpson
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Responsibilities

Prepares study binders for source document storage as instructed by Project Manager and/or Clinical Data Supervisor
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 Manager
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 Manager
Assists with all other duties as assigned
Acts as recorder for clinical activities in eSource as required
Supports clinical and PM staff as assigned

Qualification

Data inputQC reviewGCP complianceMicrosoft Office SuiteSelf-directedAttention to detailEffective communicationOrganizational skills

Required

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

Company

Quotient Sciences

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Quotient Sciences provides formulation development, clinical pharmacology, clinical & commercial manufacturing services.

Funding

Current Stage
Late Stage
Total Funding
$35M
Key Investors
TA Associates
2019-07-18Acquired
2008-09-03Private Equity· $35M

Leadership Team

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Thierry Van Nieuwenhove
Chief Executive Officer
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Company data provided by crunchbase