POSITION 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.

DUTIES AND RESPONSIBILITIES:

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.
Assists with Recruitment duties and responsibilities as requested.

JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION:

Qualifications:

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.

Education and Experience:

High school diploma or general education degree (GED) as well as experience as a Medical Assistant, EMT, LVN, Phlebotomist, Foreign Medical Graduate (FMG), or Corpsman in a clinical or laboratory setting and/or equivalent combination of medical education, training, certifications, and/or experience.

Knowledge, Skills, And Competencies Required

Skills, Knowledge, and Abilities:

Able to perform basic clinical procedures correctly including vital signs, ECGs, 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.

Competencies:

Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
Peer Relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.
Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources.
Action Oriented: Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.
Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend a broader range of activities.

Certificates and Licenses:

Basic Life Support (BLS) certification is required and may be provided by the company. GCP training is required and will be provided by the company.

Language Skills:

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.

Math Skills:

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.

Reasoning Skills:

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.

Computer Skills:

To perform this job successfully an individual should have excellent computer skills with working knowledge in the current Microsoft Office Suite as well as Microsoft Windows operating systems.

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