Clinical Research Data Coordinator Job at Medasource, Brentwood, TN

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  • Medasource
  • Brentwood, TN

Job Description

Position: Clinical Research Data Coordinator

Location: Onsite - Brentwood, TN

Duration: 6-month Contract to Hire

Schedule: Day shift; M-F - 8am-4pm

Start: ASAP

Position Summary

The Data Coordinator is responsible for EMR data abstraction, EDC data capture, assisting with AE/SAE reporting and study queries. Ensures all activities are conducted according to company SOPs, and all applicable GCP and ICH

regulations and guidelines.

Major Responsibilities:

Duties include but are not limited to:

  • Support data entry activities to meet study data needs and deadlines
  • Data abstraction from diverse sources
  • Obtain source documentation for patients enrolled into clinical trials and data registry
  • Maintain Data Registry as directed
  • Assist with Data validation, conflict resolution and quality assurance
  • Supports Clinical Project Manager to meet industry trial data deadlines
  • Obtain source documentation for patients enrolled into clinical trial
  • Assist Clinical Project Manager with case report form completion
  • Assist Clinical Project Manager with query resolution
  • Assist in SAE reporting and tracking
  • Create and maintain patient visit tracking spreadsheets
  • Maintain and archive study documents
  • Meet with clinical study sponsor representatives as requested
  • Develop and maintain file management and collaboration systems
  • Maintain calendar
  • Initiate improvements, tools, processes, and forms to enhance the efficiency and quality of work
  • Attend meetings as assigned and report on actions
  • Participate in educational activities and programs
  • Maintain strictest confidentiality
  • Work closely and effectively with all other department colleagues
  • Assist other staff as requested and performing other related work as needed.
  • Throughout the conduct of the clinical trial assesses adherence to HRI SOPS, Good Clinical Practice (GCP) and ICH regulations and guidelines
  • All other duties as assigned

Education & Experience:

  • High School Diploma - Required
  • Bachelor’s Degree - Preferred
  • 1+ years of experience in healthcare, research, or other science related field - Required

Knowledge, Skills, Abilities, Behaviors:

Knowledge:

  • Knowledge of scientific, medical, and regulatory terms
  • Must have an understanding of clinical research process
  • Knowledge of GCP and GMP

Skills: The proficiency to perform a certain task

  • Professional writing and communicating skills required
  • Organizational and prioritization skills required
  • Computer skills with ability to use clinical trial databases, electronic data capture, MS Access or Excel
  • High computer literacy and ability to learn new software if required

Abilities: An underlying, enduring trait useful for performing duties

  • Ability to work both collaboratively and independently
  • Interpersonal skills, detail oriented, and meticulous
  • Ability to multi-task in fast paced environment is essential.
  • Ability to manage, organizes, and makes decisions

Travel Required

  • No Travel: The job does not require any travel.

Job Tags

Contract work, Immediate start, Day shift,

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