PRN (Day Shift) Clinical Research RN I

CenExel•Gaithersburg, MD

12d•Onsite

About The Position

With moderate oversight, the PRN Clinical Research RN I oversees the implementation of daily clinical study activities and serves as a liaison between the investigative site and the Sponsor. The role is responsible for accurately and ethically documenting information obtained throughout the clinical research process. The initial need is for Fridays on day shift, with potential additional needs varying. This is an on-site position in an indoor clinic environment.

Requirements

Current Registered Nurse license in the state where the employee will work, with no disciplinary action on the license.
BLS or ACLS certification, or ability to obtain it.
0–1 year of experience required.
IV certification, depending on site.
Ability to perform clinical tasks relevant to licensure and/or training.
Ability to communicate clearly verbally with patients and effectively both verbally and in writing.
Good interpersonal skills when interacting with patients, staff, and sponsor representatives.
Self-motivated and able to perform tasks independently.
Ability to react calmly and effectively in emergency situations.
Ability to uphold the company vision and reflect a professional image in actions and demeanor.
Ability to sit, type, stand, and walk; occasional lifting of up to 20 pounds.
Ability to report to work as scheduled.

Responsibilities

Provide general nursing care to study participants, including monitoring vital signs and blood sugar and conducting laboratory tests.
Review and execute clinical research protocols.
Complete and maintain study documents in accordance with sponsor and site requirements.
Potentially recruit study subjects; screen subjects for eligibility and schedule study-specific assessments as designated on the Delegation of Authority Log.
Complete and maintain Case Report Forms in agreement with source documentation and study protocols.
Accompany sponsor representatives during visits and maintain ongoing communication with the sponsor.
Maintain adequate inventories of data and supplies.
Attend training, staff, initiation, study start-up, and other assigned meetings.
Observe, document, report, and follow up on adverse events and serious adverse events.
Conduct the informed consent process according to CenExel Standard Operating Procedures.
Follow up appropriately on laboratory results.
Maintain safety standards while performing job responsibilities.
Maintain study logs and site relations.
Ensure proper collection, processing, and shipment of laboratory specimens, when applicable.
Assist with quality assurance activities and complete queries as applicable.
Obtain Principal Investigator signatures on necessary documents.
Oversee or coordinate administration of investigational medication and follow subjects throughout their study stay according to protocol.
Ensure accountability and adequate supplies of study and clinical drugs.
Support and ensure adherence to FDA Code of Federal Regulations, ICH, Good Clinical Practices, CenExel standard operating procedures, site working practices, protocols, and company guidelines and policies.
Perform other duties and responsibilities as assigned.