Research Data Entry Coordinator Job – West Columbia, SC 162490

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Why You'll Love This Job

The data entry coordinator is primarily responsible for coordinating with lead study coordinator, site management, and Principal Investigator to help ensure that collected subject data is in accordance with study protocol, International Council for Harmonisation Good Clinical Practice (ICH/GCP), Federal regulations, and sponsoring agency policies and procedures.The data entry coordinator cooperates with site management, lead study coordinator and monitoring efforts to ensure study data is entered in a timely and efficient manner and reports instances of noncompliance to site management.

Responsibilities

Responsibilities:
  • Records collected subject data promptly and efficiently into study data system while maintaining HIPAA compliance.
  • Reviews subject charts for completeness and accuracy while entering subject data.
  • Ensure all corrections made by study coordinator in subject chart are legible and compliant with GCP guidelines
  • Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant medications, etc.) study visits
  • Transcribe subject study information from source documents to the Electronic Case Report Forms
  • Review study database regularly to ensure data is being entered in a timely manner and queries are being addresses/resolved.
  • Report instances of chart incompleteness and inconsistencies to lead study coordinator and/or site management.
  • Attends site initiation visits for data entry training as required.
  • Communicates with site management and lead study coordinator to ensure there are no delays or issues with data entry during study start-up, study administration, and study closeout.
  • Obtain any applicable additional/required sponsor training and/or certifications

Skills & Qualifications

Education
  • College degree preferred and/or 1 year of related work experience
  • Experience with Ophthalmology trials (Preferred)
Experience:
  • Research Coordinator Level I or Research Assistant Level II = 1 year OR 1-2 years of data entry experience in a professional setting
  • Familarity with research termonology
  • Experience supporting clinical or academic research projects preferred. 
  • Prior work involving quality assurance, data audits, or discrepancy resolution preferred. 
Skills:
  • Demonstrates ability to effectively convey ideas and information
  • Able to creatively generate ideas with excellent follow through
  • Demonstrates working knowledge of eye anatomy, disease, symptoms, and ocular medications
  • Possesses excellent organizational skills to independently manage workflow
  • Pays meticulous attention to detail
  • Takes initiative
  • Possesses insight and energy to prioritize quickly
  • Demonstrates high-level critical thinking skills
  • Cooperates with supervisory staff, physicians, peers, external customers, and patients in a positive, energetic, and professional manner
  • Abounds in organizational and time-management skills
  • Excellent interpersonal, oral, and written communication skills
  • Strong collaboration skills required. Must be able to work effectively with teams both internally and remotely
  • Teaching and facilitation skills.
  • Ability to determine training objectives
  • Organizing and coordinating skills
  • Skill in preparing instructional plans
  • Ability to use Microsoft office products such as Word, Power Point, Excel, and Access
Physical Demands:
  • Must be able to stand for long periods of time
  • Must be able to write
  • Must be able to hold arms at shoulder height
  • Must be able to communicate via telephone
  • Must have manual dexterity to work with ophthalmic equipment
  • Working hours may vary depending on the needs of the research project. There may be days when overtime hours may be necessary to ensure data is entered to meet study timelines.
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