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Clinical Research Nurse
Job Opportunity at
Vitalis Consulting LLC
Posted on Oct 13
Clinical Research Nurse
Chief Operating Officer/ Clinical Pharmacology Unit Director
1. RN with Flexible hours required - To include possibly Nights and Weekends
2. This is a Per Diem Position
3. Must be IV Certified OR trained
3. Must have some clinical research experience - (preferably phases I - II)
The Clinical Research Nurse will have responsibility for performing procedures required in clinical research studies. Must ensure that studies are carried out according to protocol, standard operating procedures, and applicable guidelines and regulations.
: 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.
Essential Duties and Responsibilities
include the following. Other duties may be assigned.
Develop a high level of familiarity and knowledge of the study protocol and flow chart of study procedures. Develop a strategy for implementing study procedures in compliance with accepted research guidelines including Health Insurance Portability and Accountability Act (HIPAA) regulations and the study protocol, including but not limited to the management of appointments for specialized examinations at the University Hospital, logistics of the study - equipment ordering, source document writing, etc.
Review and validate the study CRFs in conjunction with the Investigator and the Clinical Research Associate of the Study.
Perform study procedures (e.g., participate in screening procedures, administer study drug (infusions, oral drug administration, etc.) under the supervision of a pharmacist or physician, start intravenous lines, venipunctures, obtain biological specimen samples, obtain ECG recordings, vital signs, safety assessments, etc., and pharmacodynamic measures - psychometric tests, etc.), process blood samples as required by study protocol under the supervision of the Principal Investigator.
Record study data in the source documents. Evaluate and review study data to ensure accuracy and completeness.
Assist in transcribing study data from source documents to sponsor designated case report forms or record data for remote data entry if applicable.
Resolve data queries in conjunction with the sponsor.
Assist the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.
Maintain emergency medication in the crash cart under the responsibility of the pharmacist.
Assist in the training of other staff as required.
Maintain good communications and keep the Clinical Research Team fully informed.
Work to ensure that studies are delivered according to Sponsor requirements on time and to high quality.
Ensure that work remains in compliance with regulatory guidelines, safety requirements, quality control standards and the Company’s Standard Operating Procedures.
Work collaboratively with co-workers.
This position does not have supervisory responsibilities.
Education and Experience
A Bachelor Degree or Associate Degree in Nursing required.
Three years experience in the medical field, preferably a CRO or research environment.
Certificates, Licenses, Registrations
Active Registered Nurse (RN) license in the State of New Jersey.
Other Skills and Abilities
• Excellent communications skills with the ability to interact with investigators, the clinical research team, sponsors and members of the medical community.
Good working knowledge of Microsoft Office Suite including Word and Excel.
Ability to read, analyze and interpret common scientific and technical documents. Ability to respond to common inquiries or complaints. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from investigators, the clinical research team, sponsors, patients, employees, etc.
Thorough understanding of clinical research process.
Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with abstract and concrete variables.
Ability to work independently, efficiently and accurately with high productivity.
Experience in conducting complex long-term projects and meeting strict timelines.
Good interpersonal skills
While performing the duties of this job, the employee is regularly required to talk, give oral instructions; listen and hear instructions, patient responses, etc. The position is active and requires standing, walking, bending, kneeling and stooping all day. The employee must occasionally lift and/or move items up to 100 pounds.
This job operates in a clinical research setting. This role routinely comes into contact with healthy volunteers and patients who may have contagious illnesses. This job may on occasional work around caustic chemicals.
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