RN Clinical Research Structural Heart

Research Coordinator

Scope of work With principal investigator oversight, prepares, evaluates and implements research studies to enhance the advancement of clinical practice.

Serves as primary coordinator / project manager on a variety of research studies with low or moderate regulatory, clinical, and operational complexity; supports the PI and research team members.

Evaluates and prepares research studies for implementation including: assessment of operational feasibility; budget development; preparation of IRB documents; institutes protocol operations (generation of data collection tools, case report forms); attends study meetings.

Identifies, recruits, screens, assesses eligibility, and enrolls subjects per protocol; with appropriate training and delegation, performs protocol-required research activities.

Assesses patient status; collects, reviews, and documents data into a variety of systems per protocol.

Assesses, plans, implements and evaluates educational programs, procedure and protocol updates to meet the identified needs of physician investigators, nursing staff, program staff, patients, family and/or the community.

Maintains research studies in compliance with federal, state, and local law, GCP, contracts, and institutional policies.

Coordinates and/or performs study activities which may include: respiratory therapy assessments; identification of adverse events; investigational product/test article (drug or device) accountability and administration; collection, processing, and shipment of research specimens; and other research activities to the extent permitted by law and policy.

Communicates, collaborates, networks, and acts as a consultant to the study sponsor and/or CRO, research study centers, academic institutions, investigators, physicians/physician offices, ancillary departments, and the multidisciplinary team (including students and residents).

Qualifications

Required Bachelor's Degree or equivalent in a health or science related field

1 year of relevant experience In clinical research and project management Preferred

Registered Nurse (RN) - State of Michigan Upon Hire required

-Basic Life Support (BLS) - AHA American Heart Association 90 Days required Or

Basic Life Support (BLS) - ARC American Red Cross 90 Days required

Shipping and Handling of Specimen Training-Certification - 90 Days required

Adv Cardiovascular Life Support (ACLS) - AHA American Heart Association As Needed-required when indicated by the clinical trial protocol

Pediatric Adv Life Support (PALS) - AHA American Heart Association As Needed-required when indicated by the clinical trial protocol