Nurse Manager (Clinical Operations)

Parexel Early Phase Clinical Unitsupports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and "first in human" trials are the first step in testing these novel treatments in humans.

At Parexel Glendale Unitthe Nurse Manager will manage and assist our highly trained and skilled nurses. The nursing team is involved in administering new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. The team will monitor the volunteer participants' health status around the clock as per the trial protocol to ensure their safety and wellbeing.

Your time here:

As a Nurse Manager, you will lead the nursing team as they work on the clinical trials and are involved in all aspects of the trial development process at the Unit. You will work as part of the management team and collaborate with other departments such as Pharmacy, Screening, Laboratory, Clinical, Recruitment, and Project Management. Your work environment is fast-paced, interesting, dynamic, and rewarding.

Starting your journey with Parexel comes along with anextensive induction program and ongoing training (including Good Clinical Practice training and Immediate Life Support training)while following your individual career path.

Develop professionallyby gaining experience in delivering high-quality research projects in this growing sector.

What you'll do after training is complete(including but not limited to):

• Responsible for oversight of study participant care and study procedure assignments
• Responsible for upholding the protocol, SOPs and GCPin all work processes to ensure efficient and compliant clinical operation within the Early Phase Clinical Unit (EPCU). This includes but is not limited to daily crash and medication cart checks, oversight of Adverse Events (AEs),and review, monitoring and follow up on concomitant medications (discussing with charge nurse and PI as required).
• Responsible for tracking compliance with clinical/protocol related training to ensure understanding across the clinic floor, guiding and directing staff and others to ensure safety and protocol compliance.
• Responsible for ensuring study participant safety. This includes working with the nursing and medical teams to identify/respond to changes in the study participant's physical, mental, and/or behavior to take appropriate action. If necessary, notify physician and/or research team, documenting as required.
• Responsible for oversight of nursing assessment, administration of IP via any route as per protocol in conjunction with nurses, monitoring, recording, and reporting of patient's condition and reaction to drugs and treatments to the appropriate physician and CRC, and dispensing medication as directed.
• Work with the nursing and CRC team to plan and prepare dosing procedures/instructions (for example, preparing the Dosing Information Sheet).
• Ensure IP chain of custody is maintained in coordination with the Pharmacy.
• Assist physician or perform more complex clinical procedures as required.
• Respond, lead, and assist in emergency and code situations by following standard emergency protocols and SOPs.
• Ensure that all nursing and protocol-related procedures are completed and documented according to GCP and standard nursing practice.
• Obtain and/or support informed consent from trial participants according to GCP guidelines and SOP's, as required.
• Maintain and update professional competencies, ensuring knowledge and understanding of Clinical Operating Guidelines and related hospital policies, as applicable.
• Be the main point of contact for the nurses on shift to answer questions or assist with emergencies that may arise while on shift.
• Amenable to flexible working schedule as required by business and workflow, including shift rotations, weekend and evening work, on-call obligations, as well as an understanding that flexibility in work schedule is important to meet business needs.

Skills

• Demonstrated leadership ability and critical thinking.
• Proven emergency care, comprehensive assessment skills, or equivalent experience as applicable.
• Ability to assess, monitor and respond to emergency situations.
• Possess knowledge and skills necessary to provide care appropriate to the age and/or indication of the study participants served.
• Have the ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail.
• Excellent interpersonal, verbal, and written communication skills.
• Demonstrated competency in all research-related tasks.

Qualifications

• Education: Bachelors degree required (prefer BSN).
• RN licensure in California highly preferred.
• 3 + years of clinical experience in an acute hospital setting or comparable experience in a clinical research environment is required.
• 3 + years managing staff.
• Current Advanced Cardiac Life Support (ACLS) preferred.
• Current Basic Life Support (BLS) required.