Clinical Research Nurse

Arkansas Colleges of Health Education•Fort Smith, AR

4d•Onsite

About The Position

The Clinical Research Nurse, under the guidance and supervision of the Director of Clinical Research, ensures that the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals, and OMRC policies and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. In addition, the clinical trial nurse will act as study coordinator for designated studies.

Requirements

Valid RN license from the State of Arkansas
Minimum of a diploma from an accredited nursing school required
Two (2) years of recent clinical nursing experience in a hospital, clinic or similar health care setting (bachelor’s degree may be substituted for one (1) year work experience)
Nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG/EKG, administering injections, etc.)
CPR certification required
Knowledge of medical terminology, drug calculation skills, clinical medicine, clinical trials and GCP concepts
Detail-oriented and precise in all aspects of work
Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
Must have professional demeanor and strong communication skills with the public as well as physicians and co-workers
Ability to work well independently and in a team environment
Strong interpersonal, customer service, and multitasking skills are critical
Must be proficient in Microsoft Office Word and Excel, electronic health systems, and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire
Possess the ability to work well under pressure and manage deadlines
Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures
Display professionalism for the college in all communication and interactions.
Ability to maintain confidentiality and privacy.
Ability to prioritize and organize numerous and varied assignments.
Ability to orally communicate effectively with others with strong interpersonal skills and customer service orientation.
Ability to work cooperatively with colleagues and supervisory staff at all levels.
Ability to understand oral and written information, using the English language, and organize thoughts and ideas into effective forms of communication.
Ability to make decisions which range from moderate to a significant impact on the immediate work environment, as well as outside contributors.
Possess public communication skills that allow professional representation of ACHE to a variety of business and community customers and associates.
Strong organizational skills.
Intuitively able to reason, analyze information and events, and apply judgment in order to solve problems of both a routine and complex nature.
Expertise in negotiation.
May be exposed to short, intermittent, and/or prolonged periods of sitting and/or standing in performance of job duties.
May be required to accomplish job duties using various types of equipment/supplies to include, but not limited to pens, pencils, calculators, computer keyboards, telephone, etc.
May be required to transport oneself to other campus offices, conference rooms, and on occasion, to off-campus sites to attend meetings, conferences, workshops, seminars, etc.
Requires attendance at events representing ACHE both within as well as outside of the college setting.
Frequently required to work at a desk, conference table or in meetings of various configurations.
Frequently required to see for purposes of reading matter.
Frequently required to hear and understand speech at normal levels.
Occasionally required to lift items in a normal office environment.
Ability to safely lift and carry 25 pounds, with or without reasonable accommodation.
Frequently required to operate office and presentation equipment.

Nice To Haves

Bachelor of Nursing or other Science degree preferred
At least one (1) year of clinical trials research experience preferred

Responsibilities

Ensures compliance with each study’s protocol by providing thorough review and documentation at each subject study visit
Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements
Performs medical tests, including, but not limited to, vital signs, imaging studies, and electrocardiograms
Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects; notifies Principal Investigator of findings/issues
Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment
Documents medical data in patient chart to capture protocol requirements
Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and Good Clinical Practices (GCP) guidelines
Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
Develops accurate source materials and ensures compliance
Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and internal databases
Supports the regulatory staff in the maintenance of regulatory documents in accordance with internal SOP and applicable regulations
Interfaces with research participants, to support efforts to determine eligibility and consenting of study participants according to protocol
Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsors, monitors, PI, and study participants
Ensures compliance with research protocols by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability
Disburses investigational drug and provides patient teaching regarding administration, as necessary
Communicates and collaborates with the study team including internal and external parties, sponsors, PI, and study participants
Participates with the PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
Occasional travel to attend sponsor study training meetings as required
Other duties as assigned by the Director of Clinical Research or their designee