The Clinical Research RN I oversees daily clinical study activities and serves as a liaison between the investigative site and the Sponsor. Responsibilities include providing nursing care to participants, executing protocols, and ensuring ethical documentation of all research data.
Requirements summary
Candidates must be a Registered Nurse with a current state license and BLS or ACLS certification. The role requires 0-1 year of experience and the ability to perform clinical tasks and communicate effectively with patients.
professional certificateInterpersonal SkillsRegulatory CompliancePatient CommunicationEmergency ResponseNursing CareData DocumentationPatient ScreeningIV CertificationCase Report FormsClinical Research ProtocolsLaboratory Specimen ProcessingInformed Consent Process
Job description
CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary
With moderate oversight, the Clinical Research RN I is responsible for overseeing the implementation of daily clinical study activities. Serving as a liaison between the investigative site and the Sponsor. Responsible for accurately and ethically documenting all information obtained throughout the clinical research process.
Essential Responsibilities and Duties
Provides general nursing care to study participants as necessary; including, but not limited to monitoring of vitals, blood sugar, vital signs, lab tests, etc.
Reviews and executes clinical research protocols.
Completes and maintains study documents in accordance with sponsor and site requirements.
Possible recruitment of potential study subjects.
Screens subjects for eligibility, and schedules subjects for study specific assessments, as designated on the Delegation of Authority Log.
Completes and maintains Case Report Forms in agreement with the source documentation and in accordance with study protocol.
Accompanies sponsor representatives during their visits and maintains effective and ongoing communication with the sponsor.
Maintains adequate inventory of all data and supplies.
Regularly attends training meetings, staff meetings, initiation meetings, study start-up meetings, and other meetings as assigned.
Observes, documents, reports, and follows up on adverse events and serious adverse events.
Benefits
Dental
Vision
STD
LTD
Health Insurance
401k
Life Ins
Conducts the informed consent process, per CenExel Standard Operating Procedures.
Follows up appropriately on all laboratory results.
Maintains safety standards when performing job responsibilities.
Maintains study logs and site relations
Ensures proper collection, processing, and shipment (if applicable) of laboratory specimens.
Assists with quality assurance activities and completes queries, as applicable.
Obtains Principal Investigator signatures on necessary documents.
Oversees or coordinates the administration of investigational medication and follows subjects throughout the study stay, per protocol.
Ensures accountability and adequate supply for study and clinical drugs.
Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills
Must be a Registered Nurse with a current license in the state in which the employee will be working, and not have any disciplinary action on the license.
Must be BLS or ACLS certified or able to obtain.
0-1 year of experience is required.
Must be IV certified, depending on site.
Must be capable of performing all clinical tasks relevant to licensure and/or training.
Must be able to clearly communicate verbally with patients.
Must have good interpersonal skills, demonstrated through interactions with patients, staff, Sponsor representatives, etc.
Must be self-motivated and able to perform tasks independently.
Ability to react calmly and effectively in emergency situations.
Must reflect the professional image of the company, upholding the company vision in actions and demeanor.
Must be able to effectively communicate verbally and in writing.
Working Conditions
1. Indoor, Clinic environment. 2. Essential physical requirements include sitting, typing, standing, and walking. 3. Lightly active position, occasional lifting of up to 20 pounds. 4. Reporting to work, as scheduled, is essential. 5. On-site work arrangement.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
