Job Description

Summary:  Performs and manages all study-related clinical nursing procedures according to the study protocol and provides nursing care under appropriate supervision for subjects enrolled in clinical trials. Perform duties in accordance with ProSciento’s values, policies, and procedures.

This role has a 12-hour shift, alternative work schedule (AWS). Our current scheduling needs will require the night shift (6pm - 6am) as a priority. 

Essential Duties and Responsibilities  will   include the following. Other duties may be assigned at the company’s sole discretion.

• Administers prescribed study medications, performs phlebotomy, draws blood samples, monitors vital signs, and/or performs other specialized nursing procedures, as appropriate to the specific needs of the study and individual subjects.
• Starts peripheral intravenous lines using gauge 18 1 ¼” and double lumen catheter gauge 18 1 ¾” without use of tourniquets, as per specific study protocol.
• Performs detailed review of subject’s current meds and enters information appropriately in source document as indicated.
• Administers concomitant medications as indicated or prescribed.
• Participates in day-to-day clinical activities and procedures, ensuring efficient workflow and adequate care and treatment of research subjects.
• Completes study source documents for area of responsibility such as c-mar, fluid sheet, AE, and con med review.
• Monitors and records subject response to treatment. Queries subjects on adverse events/serious adverse events during study. Completes study specific subject information serious event intake form.
• Resolves study source document discrepancies.
• Assists in keeping adequate stock of consumable clinical inventory.
• Manages or assists with training of new hires, evaluating skills, maintaining crash cart, etc.
• Provides supervision for research assistant and clamp tech staff in the performance of nursing related protocols involved in studies including assistance in training on the specifics of phlebotomy and blood draws, proper care of specimens, and properly obtaining urine samples.
• Partners with the human resources department with respect to completion of procedures and processing including documentation and logistics for staff who have had exposure incidents.
• Manages or assists with keeping employee immunizations up to date (TB, Hep B) including maintaining associated documents.
• Develops synopses for nurse and research assistant use for each clinical trial.
• Participates in training of other nurses and/or new hires in pertinent aspects of each protocol.
• Assists in the training of research assistant staff for protocol-related and clinical procedure activities.

Competencies

• Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• 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 work flow; 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.
• 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.
• Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgement; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
• Informing: Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit, and/or the organization; provides individuals information so that they can make accurate decisions; is timely with information.

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

Bachelor of Science in nursing as well as two years RN critical/acute care experience in a hospital, clinical research, and/or similar environment or an equivalent combination of medical education, training, certifications, and/or experience.

Skills, Knowledge, and Abilities: 

Excellent IV skills necessary. Knowledge of immunizations for employers including record-keeping. Ability to work evening and overnight shifts, as required. Ability to conform to a 12-hour alternative work week shift schedule. Exercises calm judgment and actions under pressure. 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. Ability to self-monitor progress and complete assigned tasks independently.

Certificates and Licenses

Active Registered Nurse (RN) license in the State of California. BLS & ACLS certification is required and may be provided by the company.

Language Skills

Ability to read and interpret documents such as safety rules, Standard Operating Procedures (SOPs), Work Instructions (WIs), procedural manuals, governmental and clinical regulations, and similar documents. Able to communicate effectively to employees and management and in group meeting settings.

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 of the current Microsoft Office Suite as well as Microsoft Windows operating systems.

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