POSITION SUMMARY

Assists investigators 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 school, sponsoring agency, community and the study participants; responsible for managing and recording all phases of study protocol as required by the sponsoring agency to ensure compliance.

EDUCATION:

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

WORK EXPERIENCE:

No specific work experience is required for this position.

SKILLS:

Not Applicable

REQUIRED QUALIFICATIONS:

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

EDUCATION:

No additional education 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, Research Support

• 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.