Job Description

Job Overview:

Responsible for performing practical/administrative activities of clinical trials in Clinical Pharmacology in line with protocol and regulatory requirements.

Summary of Responsibilities:

Accurately perform blood pressure, pulse, weights, respiratory rate, and temperature readings. Preparation and accurate recording of ECGs/Holter's. Collection and processing of biological samples as specified in the protocol and ensures the proper distribution of those samples. Monitors meals to ensure dietary compliance by research participants. Assist with screening procedures, as necessary. Assist in the preparation of rooms and medical equipment. Maintain a clean, safe, and efficient working and study environment. Assist with QC of source documents and case report forms. Transcription of data from source documentation onto the Case Report Forms (CRFs) for simple to complex studies and QC of CRFs. Foster respectful relationships with study participants. Accurately record all research data obtained or observed. Maintains a basic understanding of current regulatory requirements. Attends all required meetings, as appropriate. Assist, as necessary, with study procedures. Maintains accurate records of all work undertaken. Maintains skills to perform all study tasks, as required. Maintains constant awareness of participant safety and dignity at all times. Handles participant complaints efficiently and effectively in order that their satisfaction is maintained. Ensures that client and participant confidentiality is maintained. Responds to client and team queries in a timely manner. Takes ownership of the quality and standard of own work. Assist with training of new staff members. Observe study subjects for general well-being and report appropriately. Check-in and check-out study participants. Works closely with Study Coordinators on FMEA, as requested. All other duties as needed or assigned.

Qualifications (Minimum Required):

Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Required: USA BS degree in related field Required: EUROPE Educated to GCSE Standard

Experience (Minimum Required):

Required: USA Associate degree in related field and 1 year of clinical research experience may be substituted for BS degree. High School diploma or equivalent and 1-2 years as a Clinical Research Technician I may be substituted for BS degree. Required: EUROPE Typically, 1-2 years in a related field.

Physical Demands/Work Environment:

Handling of biologically hazardous or radiolabeled material is necessary. Must be able to see (distinguish colors) and hear to meet, if necessary, the job requirements. Must be able to use hands to finger, handle, or touch objects, tools, or controls, including a computer keyboard, for up to 6 hours per day. Must be able to stand and/or bend for up to 6 hours per day. Rotating shifts, overtime and weekend work as required. CPR/AED Certification is required for the position. Potential travel for cross-site support needs or training needs

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