YCCI Clinical Research Nurse 2

Overview

As a member of the Yale Center for Clinical Investigation's (YCCI) research support services team, responsible for the clinical nursing care of research subjects as they undergo procedures related to their study participation. Support the Center's mission of providing the highest quality service to the clinical investigators and study participants, work collaboratively with research support staff, clinical investigators and administration to ensure the professional and accurate performance of participant education, protocol-directed activities, and data collection, while working directly in a nursing capacity including the performance of essential clinical skills, which must be current within one year, with the study participants.

YCCI supports clinical activity at the Magnetic Resonance Research Center, West Campus Research Unit, PET Center, Hospital Research Unit, and Church Street Research Unit. This position includes nursing coverage at all of these locations and any other Yale-affiliated location within the Yale School of Medicine, New Haven, CT.

The Essential Duties listed below are generic in nature. Applicants will find the detailed responsibilities listed above in this Position Focus to be most relevant to the position.

Essential Duties

• Evaluates and assesses subject’s suitability for inclusion in studies; develops and modifies procedures according to study findings; recommends changes to the study protocol to coincide with study goals and objectives.
• Develops and implements procedures and data quality assurance standards for safety monitoring components of studies.
• Contributes to designing activities, policies and procedures to improve day to day efficiency of the recruitment and assessment components of the study and to ensure that staff members perform activities within established research protocol.
• Arranges patient enrollment, determines patient eligibility and obtains informed consent.
• Develops study subject referral sources; designs and develops outreach programs.
• Collaborates with multidisciplinary researchers to coordinate research programs that integrate new advances in clinical trials.
• Delegates tasks and supervises the activities of other licensed and unlicensed care providers.
• May perform other duties as assigned.

Required Skills and Abilities

1. Ability to clearly communicate and execute informed consent with study participants. Current clinical skills to include physical assessment, health history, venipuncture, IV site establishment, access and care, ECG and vital sign acquisition, medication administration and basic emergency management with ALS or BLS and AED certification.
2. Ability to perform medical record abstraction, record clinical and laboratory data accurately and electronically according to HIPAA and HIC regulations. Ability to work independently, display excellent communication skills.
3. Ability to perform phlebotomy on adult, adolescent and pediatric study subjects when needed, transport specimens to and from clinical laboratories per protocol, when necessary. Prepares specimens for shipment to central laboratories under EHS guidance, when necessary.
4. Ability to communicate with the data coordinating center and respond to requests for information in a timely and complete fashion. Proven ability with maintaining accurate, timely and complete records regarding study enrollment and data collection with adaptability in Epic as well as other electronic data capture systems.
5. Ability to prioritize, organize and multi-task with an elevated level of proficiency. Must have some flexibility with schedule to accommodate earlier morning or later afternoon subject visits. Occasional off-hour/off-shift support may be needed. Demonstrated problem-solving and conflict resolution skills.

Preferred Skills and Abilities

1. Previous experience in interpreting clinical data in ambulatory and hospitalized patients, including ICU patients highly desirable.
2. Up-to-date training in biosafety and human subject regulations required or demonstrated ability to gain biosafety and regulatory proficiencies.
3. Bilingual in English and Spanish.

Required Licenses or Certifications

Licensure as Registered Nurse in the State of Connecticut or Connecticut license eligible.

Preferred Licenses or Certifications

SoCRA certified and if not, willingness and ability to obtain if necessary. Web browsers, Microsoft office suite (Word, Excel, PowerPoint) and database software experience required. Previous experience in clinical research strongly preferred.

Weekend Hours Required? Occasional

Evening Hours Required? Occasional

Work Days/Hours (Other than Standard)
May include any combination of days, evenings, overnights, and weekends as needed.

Required Education and Experience

Bachelor’s of Science Degree in Nursing and four years of related experience or an equivalent combination of education and experience.

Principal Responsibilities

1. Evaluates and assesses subject’s suitability for inclusion in studies; develops and modifies procedures according to study findings; recommends changes to the study protocol to coincide with study goals and objectives.
2. Develops and implements procedures and data quality assurance standards for safety monitoring components of studies.
3. Contributes to designing activities, policies and procedures to improve day to day efficiency of the recruitment and assessment components of the study and to ensure that staff members perform activities within established research protocol.
4. Arranges patient enrollment, determines patient eligibility and obtains informed consent.
5. Develops study subject referral sources; designs and develops outreach programs.
6. Collaborates with multidisciplinary researchers to coordinate research programs that integrate new advances in clinical trials.
7. Delegates tasks and supervises the activities of other licensed and unlicensed care providers.
8. May perform other duties as assigned.