Profil Institute for Clinical Research, Inc.
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at Profil Institute for Clinical Research, Inc.
Summary: Performs study-related clinical procedures according to the study protocol and provides care under appropriate supervision for subjects enrolled in clinical trials. Performs duties in accordance with ProSciento’s values, policies, and procedures.
- Understands the main objectives of each ongoing study and the study procedures for which he/she will be responsible.
- Demonstrates proficiency at performing basic clinical procedures such as vital signs, ECGs, phlebotomy, and sample processing.
- Demonstrates proficiency in documenting observations and study procedures correctly and legibly in the source document.
- Understands and demonstrates proficiency in appropriately responding to medical emergencies onsite.
- Performs study procedures as assigned.
- Observes and records data related to patient safety and study procedures.
- Ensures that all study data is recorded accurately and completely.
- Assists nursing staff and Clinical Project Managers with study procedures and patient management as directed.
- Assists in the transcription of study data from source documents to Case Report Forms (CRFs)/ (eCRFs).
- Understands and complies with Good Clinical Practices (GCPs), particularly those regarding the protection of human subjects and integrity of clinical trial data.
- Understands and complies with ProSciento Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Participates as requested in ProSciento Continuous Quality Improvement (CQI) process.
- Flexibility to work mornings, evenings, and/or overnight shifts as needed.
- Attends and participates in all required training activities.
- Participates as requested as a Clinical Operations Study Liaison.
- Assists with Screening Receptionist duties and responsibilities as requested.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
High school diploma or general education degree (GED) as well as experience as a Medical Assistant, EMT, LVN, Phlebotomist, or Corpsman in a clinical or laboratory setting and/or equivalent combination of medical education, training, certifications, and/or experience.
Skills, Knowledge, and Abilities:
Able to perform basic clinical procedures correctly including vital signs, ECGs, phlebotomy and sample processing. Demonstrates initiative and problem-solving skills. Able to respect subject confidentiality and blinding procedures. Understands medical terminology and calculations. Demonstrates a strong attention to detail with superior organizational skills. Under general supervision, exercises judgment in accordance with well-defined policies, procedures, and techniques. Able to self-monitor progress and complete assigned tasks independently.
Certificates and Licenses:
Basic Life Support (BLS) certification is required and may be provided by the company.
Must be proficient in both verbal and written English. Able to communicate effectively with both employees and management. Ability to read and interpret documents such as safety rules, WIs, SOPs, medical terminology, and procedure manuals.
Able to add, subtract, multiply, and divide in all units of measure using whole numbers, fractions and decimals. Able to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to apply common sense understanding to carry out instructions provided in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
To perform this job successfully, an individual should have basic knowledge of the current MS Office Word and Excel.
The work environment characteristics described here are representative of those an employee may encounter while performing the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; work in high, precarious places and fumes or airborne particles. The noise level in the work environment is usually quiet to moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close, distance, and peripheral vision, as well as depth perception and the ability to adjust focus. While performing the duties of this job the employee is regularly required to sit, talk and hear. The employee is frequently required to stand; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to walk, stoop, kneel, crouch, or crawl.