Scheduled Hours

40

Position Summary

Position assists investigators as a data coordinator of clinical research trials of all complexities, extracting data from the Electronic Medical Record (EMR) and other source documents and entering it into an Electronic Data Capture (EDC).May be responsible for numerous research trials simultaneously. Helps ensure the accurate collection of study- required procedures while patients are receiving protocol treatment and are in active protocol follow-up; acts as liaison between the School, trial sponsors, vendors, and the study team. Responsible for helping the clinic coordinator and Principal Investigator (PI) manage and record data for all phases of study protocol as required by sponsoring agency to ensure compliance, patient safety and welfare, and data integrity.

Job Description

Primary Duties & Responsibilities:

• Manages patient-related data across all phases of clinical trials; ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies procedural problems and/or inconsistencies
• Monitors participant’s progress throughout study, which includes documentation and reporting of adverse events; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison between WU study team, the sponsor, and Clinical Research Organization (CRO)
• Extracts clinical data from EMR and receives clinical data from other source documents and enters it in a study specific electronic data capture system (EDC).
• Assures protocol compliance and adherence by performance of quality control checks of collected data
• Evaluates all lab and clinical assessments to ensure they are completed correctly and per protocol specification. Reviews collected clinical data in conjunction with PI or sub-investigator as appropriate
• Frequently communicates with sponsors and CROs, and responds to queries.  Facilitates sponsor monitoring visits (if applicable).
• Attends patient-related, protocol, and educational meetings.  May prepare oral or written presentations related to patient updates or protocol training. Attends sponsor monitoring meetings with the PI (if applicable). Performs other duties incidental to the work described herein.
• Collects clinical data under clinical research protocols.
• Performs other duties as assigned.

Working Conditions:
Job Location/Working Conditions

• Patient care setting.

Physical Effort

• Typically sitting at desk or table.

Equipment

• Office equipment.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education:

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications:

The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role.

Basic Life Support - American Heart Association, Basic Life Support - American Red Cross

Work Experience:

No specific work experience is required for this position.

Skills:

Not Applicable

Driver's License:

A driver's license is not required for this position.

More About This Job

Required Qualifications:

• Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements).

Preferred Qualifications

Education:

No additional education beyond what is stated in the Required Qualifications section.

Certifications:

No additional certification beyond what is stated in the Required Qualifications section.

Work Experience:

No additional work experience beyond what is stated in the Required Qualifications section.

Skills:

Clinical Research, Clinical Study Protocols, Communication, Computer Systems, Interpersonal Communication, Organizing, Problem Solving, Research Support

Grade

C09

Salary Range

$47,400.00 - $71,200.00 / Annually

The salary range reflects base s