CLINICAL MEDICAL ASSISTANT

SPAULDING CLINICAL RESEARCH LLC•West Bend, WI

4d•Onsite

About The Position

This role involves ensuring clinical trials are conducted according to protocol requirements under supervision. Key responsibilities include performing meal administration, participant bag checks, vital signs and ECG measurements, urine collection, and accurate record-keeping. The position requires a thorough understanding of study procedures, adherence to Good Clinical Practice (GCP) and ICH guidelines, and maintaining all HIPAA, OSHA, and Exposure Control regulations. The Clinical Medical Assistant will follow the progress of participants, provide for their care, comfort, and safety, and participate in quality assurance of clinical research projects. Additional delegated study procedures may be assigned as needed.

Requirements

Ability to read, write and interpret the English language.
Portrays professionalism in all interactions at Spaulding Clinical.
Proficient computer skills: inclination to adopt technology to maximize efficiency.
Demonstrates strong analytical, problem solving skills.
Strong written and verbal communication skills.
Detail oriented, good organizational traits.
Self-motivated
Must be results-oriented, multi-tasking, quick learner, respond to the urgent needs of the team, and show a strong track record of meeting deadlines.
Ability to perform and record data entry via computer systems while conducting timed clinical procedures.
High school diploma or equivalent.
BLS certification required within 6 months of hire or promotion date.

Nice To Haves

Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.

Responsibilities

Performs meal administration, ensuring the correct meal and correct content is delivered to the correct study participant.
Performs participant bag checks to ensure no contraband is present on study floor.
Performs study activities such as vital signs and ECG positioning, or other study procedures requiring supervision of study participants.
Performs and records vital sign measurements (blood pressure, pulse oximetry, heart rate, temperature, respirations, etc.).
Performs urine collection for drug screen and analysis, ensuring proper instructions for sample are given to participants and proper sample requirements are met.
Places ECG electrodes and leads accurately and performs quality check to ensure precise telemetry monitoring.
Performs additional task list items as delegated and supervised by Charge Staff.
Reviews Study Specific Trainings and applicable protocols for a thorough understanding of the study procedures, as they apply to their role and ensures that Delegation of Authority/Training Log for each study is completed in a proper and timely manner.
Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
Observes and maintains all HIPAA, OSHA, and Exposure Control regulations and Emergency Response as required by applicable training.
Creates and maintains accurate records of all protocol activities and events, as delegated and trained.
Follows progress of participants and provides for their care, comfort, and safety by attending to their needs during study participation.
Participates in quality assurance of clinical research projects and initiates the need for same as it impacts on clinical practice.
As required for study or site needs and if trained and delegated may be assigned study procedures such as obtaining participant information/histories/questionaries/meals/vital signs/EKGs/drug administration/specimen collection/luggage searches.