POSITION SUMMARY

Position 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 arrhythmia 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.
• Inputs and manages data in a specialized arrhythmia cardiac surgery database.
• Performs other duties incidental to the work described above.