Assists investigators as coordinator of a 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; manages and records all phases of study protocol as required by sponsoring agency to ensure compliance.
Requirements
- Basic Life Support certification must be obtained within one month of hire date.
- Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirement).
- One year experience in public health, epidemiological, behavioral medicine, psychological, sociological, anthropological, clinical, or urban planning research.
- Working knowledge of qualitative and/or quantitative data analysis software
- Working knowledge of computer programs and systems.
- Data management and analytic skills, particularly experience managing or analyzing large data sets.
- Clinical Research, Clinical Study Protocols, Database Management, Research Projects, Spreadsheet Analysis, Statistical Analysis Software (SAS)
Responsibilities
- Routinely 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 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 IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
- Routinely 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.
- Routinely 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 in conjunction with PI as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same.
- Routinely involves in qualitative study projects to include interviewing participants, transcribing, and coding study interviews, assisting in data analysis and manuscript writings
- Routinely collects clinical data under clinical research protocols.
Other
- Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
- Clinical Research (2 Years)
- Communication, organizational and interpersonal skills.
- Solid communication organizational and interpersonal skills.
