POSITION SUMMARY

Functions as the lead person on a research project; coordinates enrollment of study subjects; ensures adherence to study procedures consistent with the study protocol and verifiable source documentation; may supervise personnel assigned to work on the study. Coordinates with multidisciplinary teams to maintain continuity of care and human subject protection with a commitment to research integrity. May perform duties inclusive of those delegated to a Research Nurse Coordinator I.

EDUCATION:

A diploma, certification or degree is not required.

WORK EXPERIENCE:

Related Nursing Or Research (2 Years)

SKILLS:

Not Applicable

REQUIRED QUALIFICATIONS:

• Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements).

PREFERRED QUALIFICATIONS:

• Clinical Research Certification.

EDUCATION:

B.S. - Bachelor of Science - Nursing, B.S.N. - Bachelor of Science in Nursing

WORK EXPERIENCE:

Academic Research Setting (2 Years)

SKILLS:

Active Listening, Clinical Research Coordination, Clinical Research Management, Clinical Research Methods, Clinical Research Operations, Clinical Techniques, Database Management, Detail-Oriented, Effective Written Communication, Electronic Health Records (EHR), Nursing Fundamentals, Oral Communications, Patient Recruitment, Reporting Tools, Spreadsheet Software, Statistical Analysis Software (SAS), Team Collaboration

• Works under the Principal Investigator’s (PI) guidance to meet the research objective of the project.
• Facilitates and implements study start-up activities including (but not limited to): trial feasibility assessment; study logistics; IRB (both local and central) submissions and other applicable regulatory requirements; budgetary and contract review and approval.
• Provides direct patient care, including assessment, planning, implementation and evaluation of patients; documents, collects data and assists physicians.
• Works with research team to identify, screen and enroll study subjects.
• Ensures protocol requirements are met including (but not limited to): direct contact with research participants; collection of basic health information; coordination of study related procedures; handling, processing and shipping of research specimens, source documentation and data entry.
• May train and supervise staff assigned to work on the research project(s).
• Coordinates handling of specimens, administration of clinical trials, collection of source information and case reporting.
• Prepares/submits reportable event reports to sponsor(s), IRBs and regulatory agencies in accordance with the study protocol and established policies, procedures, and regulations.
• Collaborates with sponsor’s research associates during monitoring activities by providing study documentation, data clarifications and reports as necessary.
• Authorizes payments to ancillary organizations for services rendered and reconciles payments from organizations serviced.
• Demonstrates experience in clinical trials management including strong organizational skills, independence and resourcefulness and an increased responsibility for the day-to-day conduction and oversight of multiple clinical trials.
• Provides oversight of administration of study medications and/or study interventions, as appropriate. Administers investigational products in approved settings.
• Educates staff nurses caring for research patients by providing necessary information about the research study including intervention and potential adverse events and required study procedures.
• Performs other duties incidental to the work described above.