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.
Required Skill/ability 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.
Required Skill/ability 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.
Required Skill/ability 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.
Required Skill/ability 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.
Required Skill/ability 5: Ability to prioritize, organize and multi-task with a high 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 Education: Previous experience in interpreting clinical data in ambulatory and hospitalized patients, including ICU patients highly desirable. Up-to-date training in biosafety and human subject regulations required or demonstrated ability to gain biosafety and regulatory proficiencies.
Work Week: Flexible or Non-Standard (for anything other than Standard)
Posting Position Title: Clinical Research Nurse 2
University Job Title: YCCI Clinical Research Nurse 2
Preferred Education, Experience and Skills: Previous experience in interpreting clinical data in ambulatory and hospitalized patients, including ICU patients highly desirable. Up-to-date training in biosafety and human subject regulations required or demonstrated ability to gain biosafety and regulatory proficiencies.
Bachelor's of Science Degree in Nursing and four years of related experience or an equivalent combination of education and experience.
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.