LOCATION
This position is fully on-site and requires a regular presence in Fort Smith, Arkansas. Remote or hybrid work is not available for this position.
JOB SUMMARY
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.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
Nursing Care to Study Patients
- 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
Study Coordination
- 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
Other Functions and Responsibilities
- 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
- No supervisory responsibilities
- Other duties as assigned by the Director of Clinical Research or their designee
QUALIFICATIONS AND CREDENTIALS
Education and Experience
Minimum Qualifications
- Valid RN license from the State of Arkansas
- Minimum of a diploma from an accredited nursing school required; Bachelor of Nursing or other Science degree preferred
- 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
Preferred Qualifications
- At least one (1) year of clinical trials research experience preferred
Required Knowledge, Skills, and Abilities
- 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.
ABILITIES AND COMPETENCIES ESSENTIAL TO THE FUNCTION OF THE JOB
Communication and Comprehension
ACHE is in full compliance with the Americans with Disabilities Act (ADA) and does not discriminate regarding applicants or employees with disabilities and will make reasonable accommodations when necessary. The following are essential abilities and physical requirements for all positions at the college.
- 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.
Problem Solving
- 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.
Physical and Sensory Abilities
- 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.
- May require significant travel or work away from campus.
- 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.
If you need assistance in the application process because of a disability, or any other reason, please contact Vicki Broadaway, Vice President and Chief People Officer, at 479.308.2290 or [email protected].
Arkansas Colleges of Health Education is an equal opportunity employer.
