Clinical Research RN Sr (Night Shift)

About Us :

Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

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 :

The Clinical Research RN Sr. is independently 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. May train and lead lower level staff.

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.
• 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 :

Working Conditions

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.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.