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Clinical Research Nurse

2 months ago

New Haven, United States Calyx Full time

Clinical Research Nurse, I New Haven, CT

Invicro/Calyx

The Clinic department operates for the purpose of conducting early phase and later phase treatment trials, as well as biomarker and imaging studies for participants (healthy volunteer and disease populations). The imaging research focuses on in-house functional imaging technology using Positron Emission Tomography (PET) and Single Photon Emission Computerized Tomography (SPECT). This research provides methods of early detection and effective treatment, and ultimately the prevention of various disease conditions.

The Clinical Research Nurse executes research studies in accordance with scientific, medical, and ethical principles, within regulatory requirements/guidelines, and SOPs. Under the direction of the Principal Investigator and Head of the Clinic department, they undertake all essential, operational, and participant care responsibilities associated with day-to-day clinical trial and study visit activities, while following good clinical practice guidelines. The Research Nurse conducts specific aspects of protocols and policies for research studies within scope of the nursing license in Connecticut.

The Clinic is a fast-paced department that requires efficient organization, oversight, coordination, and conduct of small single-site and large multi-center clinical trials. This position is primarily responsible for the accurate completion of clinical visit procedures and collection of information for study participants according to clinical protocols, and for protecting the health, safety, and welfare of research participants. The ideal candidate is flexible, accountable, and able to manage multiple competing activities while working in a multidisciplinary team environment. Candidates must have exceptional communication skills and the ability to converse with patients and their caregivers throughout the course of their participation.

The Clinical Research Nurse, I functions under the direction of experienced clinical staff to provide participant care and human subject protection, while using professional judgment and sound decision making in the context of the clinical research setting.

Essential Functions

  • Coordinates clinical research trials from study initiation through the close-out phase of the project.
  • Able to manage several projects concurrently while balancing competing priorities and deadlines.
  • Participates in the delivery of training for new protocols, including, the creation of training materials, protocol-specific documentation, nursing in-service presentations and others as required
  • Responsible for recruiting and scheduling of study participants.
  • Creates and updates recruitment-related documents for subject use as appropriate.
  • Conducts informed consent process to ensure participants are adequately informed and competent to make a voluntary decision on whether to participate in a clinical trial.
  • Demonstrates competency in required clinical skills within the nursing scope of practice as defined by the Connecticut Department of Health (vital sign measurement, phlebotomy and venipuncture techniques, arterial line maintenance, performing and understanding of electrocardiograms, and the preparation/management/administration of investigational medicinal product).
  • Conducts and assists with study procedures, including but not limited to the administration of investigational drugs, performance of investigational imaging procedures, lumbar punctures and CSF collection, skin punch biopsy, arterial line maintenance, IV placement, and blood sampling.
  • Performs clinical procedures including, but not limited to collecting and preparing laboratory specimens (i.e., urine drug testing, safety labs, etc.) and shipping of samples. Ensures diagnostic specimens are packaged and shipped per IATA (International Air Transport Association) guidelines.
  • Interviews participants for collection of medical history, social history, concomitant medication review, and adverse event information.
  • Performs neuropsychological assessments and cognitive testing.
  • Assists imaging staff with imaging procedures (SPECT/PET) and associated clinical activities, including source document review.
  • Provides direct, face-to-face instruction and support to the trial subjects with an emphasis on participants safety and comfort including basic first aid and supportive nursing care as needed.
  • Nursing and emergency interventions are appropriate, immediate, and demonstrate excellent assessment skills and standard of care.
  • Delivers compassionate support, attention, and assistance to participants and families.
  • Explains imaging procedures and safety precautions to subjects and study partners of different educational backgrounds, cultures, and cognitive abilities; able to answer questions effectively.
  • Empathic, patient, and able to assist anxious or cognitively compromised patients during what can be disorienting or stressful procedures.
  • Assesses patient participation continuously considering ethical considerations.
  • Participates in creating and maintaining departmental SOPs/WIDs and policies to enhance overall efficiency and safety.
  • Develops, maintains and version controls source documents and tracking logs relevant to the study.
  • Prepares subject charts and source documents and maintains tracking logs relevant to clinical studies.
  • Filing, maintenance, and tracking of clinic charts, both onsite and offsite
  • Completes real-time data entry into the Case Report Forms within the Electronic Data Capture system, as well as timely query resolution for accuracy and completeness.
  • Ability to work collaboratively with other members of the clinical research team.Works closely with other cross functional departments (i.e. Chemistry, Quality Assurance, Data Management, Regulatory, Project Management, Medical Writing, Image Analysis, etc.)
  • Ability to work cooperatively with staff, ability to handle frequent interruptions and adapt to changes in the work schedule and workloads; to set priorities; to solve problems; and to respond quickly to emergency requests.
  • Manages relationships with vendors and sponsor/CRO teams.
  • Performs duties in a safe and timely manner as needed to ensure the goals of the department are met.
  • Reports and documents any issue/incident/discrepancies in the conduct of a study.
  • Additional responsibilities as required by individual project requirements and duties based on department needs.

Qualifications

Bachelors Degree in registered nursing or ASN/RN Diploma with equivalent experience

Active Connecticut state licensure as a registered nurse

Certification in basic life support (BLS), required

  • Excellent knowledge of medical conditions, medical terminology, nursing and research techniques, and application of clinical research
  • Understanding and comprehension of scientific writing
  • Detailed understanding of Phase I-IV drug development
  • Ability to review and understand emerging safety data of a drug candidate and recognize potential serious adverse effects
  • Knowledge of Good Clinical Practices (GCP) and other Regulations
  • Experience and understanding of effective electronic communication methods (i.e., Email, Video Conferencing, Slack, etc.)
  • Computer competency including a strong knowledge of computer applications and proficiency in Microsoft (MS) Office and the ability to learn different software programs
  • Well-developed clinical, analytical and organizational skills
  • Demonstrate the ability to make effective multifaceted decisions under pressure and ability to manage competing demands in a complex environment
  • Possess strong interpersonal skills when interacting with participants and working with multifunctional and interdepartmental management teams.
  • Change agile: open and receptive, flexible and adaptable.

Preferred

Experience in pharmaceutical or medical research position preferred, but not required

Experience with patients affected by CNS disorders or oncology (i.e., Parkinsons Disease, Alzheimers Disease, Multiple Sclerosis, etc.)

Familiarity with imaging (i.e., PET, SPECT, MRI) preferred, but not required

Advanced cardiovascular life support (ACLS), preferred, but not required

Proficiency in data management tools and electronic data capture systems

Other

This position follows a Monday to Friday schedule: 8am-5pm. It requires alternative or additional hours and (weekends/evenings/nights) to provide adequate study activity coverage. This position is ineligible for hybrid or remote work opportunities.

Physical requirements Ability to lift a minimum 50 pounds (22.7 kg) without assistance

Trained in patient transferring and ability to position and reposition subjects

Occupational Exposure/Risk Potential - Bloodborne pathogens or bodily fluid (Applicable)

Occupational Exposure/Risk Potential Ionizing Radiation Exposure (Applicable)

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