Clinical Research Nurse C

Clinial Research Nurse C

Provides leadership in the coordination of clinical trials and unit-related projects. Oversees study approvals, participant enrollment and consent, visit scheduling, medication administration, data collection, and regulatory documentation to ensure compliance with institutional and sponsor requirements. Serves in a lead capacity by guiding research coordinators and assistants, supporting project timelines, and preparing for monitoring visits and audits.

Job Responsibilities

• Coordinate the conduct of Phase I – IV clinical trials including consenting, screening and enrolling eligible subjects, follow GCP guidelines in the conduct of trials, coordinate implementation of research protocols with study and clinical team, collecting and reporting research data, reporting serious adverse events per protocol, coordinate subject care with clinical team, provide coverage and support to other research nurses and coordinators
• Managing subject treatment per protocol, oversight and coordination of research testing, including labs, office visits and radiology exams, provide oversight for research medication administration, monitor patient care, treatment side effects and patient status throughout study period, communicate any research issues to PI
• Communication with research team, including Investigators
• Participate in research team meetings, assist with staff /study team education, participate in study-related meetings
• Other duties and responsibilities as assigned

Clinical Research Nurse D

• Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation
• Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel according to applicable regulations and policies
• Coordinate the administration of the investigational product and study related medications including obtaining orders, scheduling administration dates, administration of investigational and study related medications (as applicable), monitoring subjects for post-administration adverse events or reactions
• Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures. Ensure preparation of all required study related documents for submission to all applicable institutional committees for review and approval to start trial.
• Ensure preparation of study related document templates (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start up
• Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures. Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events
• Assist with protocol development to ensure logistical feasibility of all study related procedures and study work-flow
• Orient and mentor new unit staff and function as resource for current staff
• Other duties and responsibilities as assigned

Qualifications

• Clinical Research Nurse C

• Bachelor's degree and 2-3 years of experience along with Registered Nurse with Licensure in Commonwealth of Pennsylvania without restriction or limitation required. BSN preferred.

• Clinical Research Nurse D

• Bachelor's degree and 5-7 years of experience along with Registered Nurse with Licensure in Commonwealth of Pennsylvania without restriction or limitation required. BSN preferred.

• This position is contingent upon grant funding