Job Description

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.

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