Clinical Research Nurse
1 day ago
We are seeking a highly skilled and experienced Clinical Research Nurse to join our team at Perceptive Inc. The successful candidate will be responsible for executing research studies in accordance with scientific, medical, and ethical principles, within regulatory requirements/guidelines, and SOPs.
Key Responsibilities:- Coordinate clinical research trials from study initiation through the close-out phase of the project.
- Manage several projects concurrently while balancing competing priorities and deadlines.
- Participate 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 by specific.
- Recruit and schedule study participants.
- Create and update recruitment-related documents for subject use as appropriate.
- Conduct informed consent process to ensure participants are competent to make a voluntary decision on whether to participate in a clinical trial.
- Demonstrate 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 management/administration of investigational medicinal product).
- Conduct and assist 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, and blood sampling.
- Perform clinical procedures including, but not limited to collecting and preparing laboratory specimens (i.e., urine drug testing, safety labs, etc.) and shipping of samples. Ensure diagnostic specimens are packaged and shipped per IATA (International Air Transport Association) guidelines.
- Interview participants for collection of medical history, social history, concomitant medication review, and adverse event information.
- Perform neuropsychological assessments and cognitive testing.
- Assist imaging staff with imaging procedures (SPECT/PET) and associated clinical activities, including source document review.
- Provide 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.
- Deliver compassionate support, attention, and assistance to participants and families.
- Explain imaging procedures and safety precautions to subjects and study partners of different educational backgrounds, culture, 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.
- Assess patient participation continuously considering ethical considerations.
- Participate in creating and maintaining departmental imaging SOPs/WIDs and policies to enhance overall efficiency and safety.
- Develop, maintain, and version control source documents and tracking logs relevant to the study.
- Prepare subject charts and source documents and maintain tracking logs relevant to clinical studies.
- Filing, maintenance, and tracking of clinic charts, both onsite and offsite.
- Complete 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.
- Manage relationships with vendors and sponsor/CRO teams.
- Perform duties in a safe and timely manner as needed to ensure the goals of the department are met.
- Report and document any issue/incident/discrepancies in the conduct of a study.
- Additional responsibilities as required by individual project requirements and duties based on department needs.
- Other Duties as assigned.
- Bachelor's Degree in registered nursing &/or equivalent experience in a related field.
- 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.
- Experience in pharmaceutical or medical research position, preferred.
- Experience with patients affected by CNS disorders or oncology (i.e., Parkinson's Disease, Alzheimer's Disease, Multiple Sclerosis, etc.).
- Familiarity with imaging (i.e., PET, SPECT, MRI) preferred, but not required.
- Advanced cardiovascular life support (ACLS), preferred.
- Proficiency in data management tools and electronic data capture systems.
- 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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