Clinical Research Assistant II

Job Description

Job Description

Position Summary

The Clinical Research Assistant provides direct support to Clinical Research Coordinators and Investigators in the conduct of clinical trials. This position is designed as a developmental role in which the employee will be trained to perform clinical and administrative research responsibilities while ensuring compliance with study protocols, Good Clinical Practice (GCP), HIPAA, sponsor requirements, and FDA regulations.

Essential Job Functions (Must Do)

Clinical Study Activities

• Assist Clinical Research Coordinators with participant study visits.
• Prepare examination rooms and study materials for participant visits.
• Obtain informed consent from study participants after appropriate training and delegation by the Principal Investigator.
• Collect participant medical history and current medication information.
• Measure and document vital signs, including blood pressure, pulse, temperature, height, weight, and respirations.
• Perform 12-lead electrocardiograms (EKGs) following protocol requirements.
• Collect, process, package, and ship laboratory specimens according to sponsor and laboratory guidelines.
• Maintain laboratory equipment and supplies.

Participant Recruitment & Screening

• Conduct telephone pre-screenings using approved study-specific questionnaires.
• Schedule participant screening and follow-up visits.
• Review inclusion and exclusion criteria with potential participants.
• Maintain recruitment logs and screening documentation.
• Assist with participant retention activities and follow-up communications.

Documentation & Data Management

• Accurately complete source documentation during participant visits.
• Enter study data into sponsor electronic data capture (EDC) systems and internal databases.
• Maintain participant files, study binders, and regulatory documents.
• Review study documentation for completeness and accuracy.
• Scan, file, and organize study records according to company procedures.

Compliance

• Maintain participant confidentiality in accordance with HIPAA requirements.
• Follow Good Clinical Practice (GCP), FDA regulations, study protocols, and MediSphere Standard Operating Procedures.
• Assist with sponsor monitoring visits, audits, and regulatory inspections.
• Complete required training and maintain research certifications.

Administrative Support

• Answer participant telephone inquiries.
• Schedule appointments and maintain study calendars.
• Maintain study supply inventory.
• Assist with general office and clinical operations.

Other Related Duties

• Cross-train in additional Clinical Research Coordinator responsibilities as assigned.
• Prepare study materials for monitoring visits and investigator meetings.
• Assist with quality assurance and quality control activities.
• Maintain clean, organized examination rooms and laboratory areas.
• Participate in staff meetings and required continuing education.
• Support coworkers during periods of high workload.
• Perform other duties as assigned by the Clinical Research Manager, Principal Investigator, or executive leadership.

Qualifications

Required

• High school diploma or GED.
• Certified Medical Assistant (CMA), Registered Medical Assistant (RMA), Licensed Practical Nurse (LPN), Paramedic, EMT, or equivalent healthcare experience preferred.
• Strong interpersonal and communication skills.
• Excellent organizational skills and attention to detail.
• Basic computer proficiency, including Microsoft Office.

Preferred

• Experience in a medical office, clinical research, or healthcare setting.
• Current CPR certification.
• Phlebotomy experience or willingness to become proficient.
• Knowledge of Good Clinical Practice (GCP), HIPAA, and FDA regulations.

MediSphere Medical Research Center, LLC is a premier independent clinical research center in Evansville, IN. Established in 1992, we collaborate with global pharmaceutical leaders to conduct Phase II–IV medical trials. Our mission is to advance innovative treatments and improve patient lives through ethical, high-standard clinical research and compassionate community care.

Company Description

MediSphere Medical Research Center, LLC is a premier independent clinical research center in Evansville, IN. Established in 1992, we collaborate with global pharmaceutical leaders to conduct Phase II–IV medical trials. Our mission is to advance innovative treatments and improve patient lives through ethical, high-standard clinical research and compassionate community care.