"Clinical Research Coordinator I - Obstetrics and Gynecology"

Position Summary

This research coordinator position will work with pregnant patients that experience some form of substance abuse. Experience with vulnerable patient populations is desired. This position assists investigators and research team members as coordinator of a basic to moderately complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the OB clinics, sponsoring agency, community and the study participants; responsible for managing and recording all phases of study protocol as required by sponsoring agency to ensure compliance. This position will include screening, enrolling, completing study visits, data entry and study management for multiple studies. This research coordinator will also work specifically with qualitative data, patient interviews, and coding.

Job Description

Primary Duties & Responsibilities:

• Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as to when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
• Recruits and enrolls study participants; makes and/or participates in making determinations of eligibility based on diagnostic criteria and/or observations/analysis in participant interviews; develops informed consent packets for study participants and confers with participants to explain purpose of study and obtain completed informed consent packets; explains diagnostic procedures and treatment plans to address participant/family concerns; administers/scores tests and/or evaluates all lab and clinical assessments to ensure they are completed in a timely manner.
• Ensures timely completion of all protocol requirements (assessment, lab testing, procedures and treatments), to include scheduling and facilitating the patient’s timely completion of protocol requirements; evaluates and interprets collected clinical data as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same.
• 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.

Required Qualifications

Education: Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
Certifications/Professional Licenses: Basic Life Support - American Heart Association, Basic Life Support - American Red Cross
Work Experience: No specific work experience is required for this position.

Required Qualifications

• Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Basic Life Support certification must be obtained within one month of hire date.

Preferred Qualifications

Work Experience: Experience in this field is preferred.
Skills: Blood Specimen Collection, Clinical Research, Clinical Study Protocols, Communication, Computer Systems, Data Management, Data Organization, Epic EHR, Good Clinical Practice (GCP), Interpersonal Communication, Organizing, Qualitative Analysis, Qualitative Research, Regulatory Compliance, Regulatory Documents, Research Support

Grade

C09

Salary Range

$47,400.00 - $71,200.00 / Annually