Clinical Data Coordinator

Raleigh, North Carolina (Remote)

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Posted 2 days ago

Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are revolutionizing the clinical trial industry, one patient, at a time. To help us achieve our goal, we are seeking a razor-sharp Clinical Data Coordinator eager to make an impact within a mission-driven organization.

The Clinical Data Coordinator (CDC) works in conjunction with the Clinical study team. Participates in and executes designated Data Management functions in accordance with Science 37 Standard Operating Procedures (SOPs).  

Duties & Responsibilities

Duties include but are not limited to:

  1. Work concurrently on multiple data management projects with minimal guidance from line manager or experienced colleagues
  2. Support User Acceptance Testing (UAT) for validation (edit) programs, as requested
  3. Test data entry screens, per data entry guidelines and / or Case Report Forms (CRFs) for selected project/s
  4. Assist in reviewing / writing / editing sections of the Data Management Plan (DMP) and / or eCRF Completion Guidelines under the direction of the Clinical Data Manager
  5. Continually:
    1. Apply DMP changes to daily work activities
    2. Generate complex data queries as directed by Clinical Data Manager with minimal guidance required and/or reference data issues log to resolve queries whenever possible
    3. Conduct quality control processes
  6. Independently:
    1. Perform additional data cleaning tasks, such as logic checks using listings and reports
    2. Serious Adverse Event (SAE) reconciliation
    3. Identify and report issues and data trends
    4. Communicate issues and concerns along with suggested resolution
    5. QC datasets
    6. Perform interpretations of compare output and provide feedback to the Clinical Data Manager for resolution and / or updates
  7. Reconcile project files, reports, listings, and other documents generated in data management against the Electronic Data Capture (EDC) database for accuracy and completeness of data management processes
  8. Provide guidance and /or training to Assistant level and newly hired CDCs
  9. Perform all tasks relevant to Science 37 SOPs, ICH, and / or other regulatory guidelines in Data Management
  10. Perform other duties as required by the Department

Qualifications

  1. Associate’s/BSc degree in biological science or a related discipline in the science/healthcare field or equivalent education
  2. Minimum 2-4 years of experience in CDM or Biostatistics in a CRO or pharmaceutical industry, or an equivalent combination of education to successfully perform the key responsibilities of the job

Skills/Competencies

  1. Good knowledge in all technical elements of Data Management
  2. Skilled in Microsoft / Google applications
  3. Good understanding of medical terminology and clinical research terminology
  4. Communicates effectively through both written and verbal methods
  5. Good understanding of ICH-GCP principles
  6. Manages time effectively in order to produce quality deliverables in expected timeframe
  7. Demonstrated ability to provide coaching and / or training to new hires and / or less experienced colleagues

Capabilities 

  1. Experience and / or willingness to work in a fast-paced, growth-minded startup, and are comfortable being flexible and adaptable as requirements change
  2. Knowledge of the drug development process
  3. Ability to establish and maintain positive team relationships
  4. Ability to articulate ideas both technical and non-technical
  5. Ability to foster concepts of teamwork, cooperation, self-control, and flexibility
  6. Possess high level of attention to detail, outstanding organizational skills and has a good blend of analytical skills, strategic thinking, planning, and implementation

Supervision

The incumbent reports directly to the Senior Clinical Data Manager, Manager (all levels) or Director (all levels)

Directo Reports

None

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. 

Submit your resume to apply!

Job tags: Coaching Reconciliation Research SOPs Strategic thinking Training
Job region(s): North America
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