Clinical Research Nurse I

2 weeks ago

Gaithersburg, Maryland, United States CenExel Full time
About Us

CenExel's research sites specialize in Phase I to Phase IV clinical trials, with Centers of Excellence that are among the most well-respected and long-standing research facilities in the country.

Job Summary

As a Clinical Research RN I, you will oversee the implementation of daily clinical study activities, serving as a liaison between the investigative site and the Sponsor. Your primary responsibility will be to accurately and ethically document all information obtained throughout the clinical research process.

Essential Responsibilities and Duties
  • Provide general nursing care to study participants as necessary, including monitoring of vitals, blood sugar, vital signs, lab tests, etc.
  • Review and execute clinical research protocols.
  • Complete and maintain study documents in accordance with sponsor and site requirements.
  • Possible recruitment of potential study subjects.
  • Screen subjects for eligibility and schedule them for study-specific assessments, as designated on the Delegation of Authority Log.
  • Complete and maintain Case Report Forms in agreement with the source documentation and in accordance with study protocol.
  • Accompany sponsor representatives during their visits and maintain effective and ongoing communication with the sponsor.
  • Maintain adequate inventory of all data and supplies.
  • Regularly attend training meetings, staff meetings, initiation meetings, study start-up meetings, and other meetings as assigned.
  • Observe, document, report, and follow up on adverse events and serious adverse events.
  • Conduct the informed consent process, per CenExel Standard Operating Procedures.
  • Follow up appropriately on all laboratory results.
  • Maintain safety standards when performing job responsibilities.
  • Maintain study logs and site relations.
  • Ensure proper collection, processing, and shipment (if applicable) of laboratory specimens.
  • Be on call to answer questions for other members of support staff, study patients, or other medical staff, as necessary.
  • Assist with quality assurance activities and complete queries, as applicable.
  • Obtain Principal Investigator signatures on necessary documents.
  • Oversee or coordinate the administration of investigational medication and follow subjects throughout the study stay, per protocol.
  • Ensure accountability and adequate supply for study and clinical drugs.
Education/Experience/Skills

To be successful in this role, you must have:

  • Proper experience and demonstrate mastery of Clinical Research RN I and II positions.
  • Be a Registered Nurse with a current license in the state in which you will be working.
  • Be capable of performing all clinical tasks relevant to licensure and/or training.
  • Be able to clearly communicate verbally with patients.
  • Have good interpersonal skills, demonstrated through interactions with patients, staff, Sponsor representatives, etc.
  • Be self-motivated and able to perform tasks independently.
  • Ability to react calmly and effectively in emergency situations.
  • Reflect the professional image of the company, upholding the company vision in actions and demeanor.
Working Conditions

This is an indoor, clinic environment that requires sitting, typing, standing, and walking. The position is lightly active, with occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential.

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.

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