Clinical Research Nurse Coordinator

The Clinical Research Nurse Coordinator conducts clinical research trial activities on behalf of SC and works with SC Investigators, SC staff, and the pharmaceutical/medical device Sponsors. Additionally, this position is responsible for the administration and oversight of investigational product as required by state law and licensure.

Job Relationships

• Reports to the Clinical Research Manager

Principal Responsibilities

• Plan and coordinate the initiation of assigned IRB approved clinical trial protocols; following all federal/local requirements, ICH/GCP, OSHA, IATA requirements.
• Responsible for screening, consenting, and enrolling eligible patients, as well as following all enrolled study patients to study completion; conduct study visits per protocol, and collect, process, and ship all lab specimens as required and as per IATA training and certification.
• Responsible for providing SC Investigators with information about the protocol, protocol amendments, Investigator's Brochure, ICH/GCP guidelines, and other study-required training to ensure compliance with all applicable regulations and study-specific guidelines.
• Maintain adequate and accurate source documentation in each of the study patient's medical records regarding their participation in the clinical study; accurately enter data into the sponsor's case report forms per the sponsor's guidelines; maintain accurate investigational product accountability documentation regarding the receipt, disposition, dispensation, return and destruction.
• Monitor research patients for suspected adverse events and report serious adverse events (SAEs) and any protocol deviations to the study sponsor within the appropriate time frame; provide pertinent information for submission to the proper authorities.
• Schedule and meet with the study monitors/Clinical Research Associates (CRAs) to:
• Review data entry against source documentation and assist in resolving all discrepancies, including resolving data queries.
• Liaise between the study monitor, clinic staff, and the SC Investigators to ensure that quality research is being conducted according to the IRB approved protocol, amendments, procedures, laws, and regulations.
• Assist management team in the training and mentoring of new/ lesser experienced staff.
• As needed, obtain and maintain Allied Health Professional appointments at the local hospitals.
• Responsible handling and administration of investigational product as appropriately delegated and trained per protocol-specific guidelines. As delegated, licensed RN's are responsible for the administration and oversight of investigational product via the following routes: intravenous, injectable, and/or oral.
• Comply with the Springfield Clinic incident reporting policy and procedures.
• Provide excellent customer service and adhere to SC Code of Conduct and Ethics Standards.
• Perform other job duties as assigned.

Education/Experience

• Licensed by the State of Illinois as an RN with three-five+ (3-5+) years of medical experience.
• Clinical Research experience strongly preferred.

Licenses/Certificates

• RN License in the State of IL.
• CPR certification per American Heart Association guidelines required within 30 days of hire.
• It is strongly recommended that research certification (CCRP or CCRC) is obtained after two (2) years of employment and then subsequently maintained in good standing.

Knowledge, Skills and Abilities

• A strong working knowledge of computer software including Microsoft Office, Electronic Medical Record(s), other SC platforms, and Sponsor required systems.
• Attention to detail and ability to follow and interpret approved clinical protocols is required.
• A strong working knowledge of GCP, ICH, CFR, and HIPAA laws and regulations will be required.
• Knowledge of Springfield Clinic policies and procedures.
• Ability to demonstrate good organizational skills, excellent oral & written communication skills, and excellent interpersonal skills in working effectively with Co-workers; Managers; Directors; Administration; Providers; Staff; Sponsors and Patients.
• Ability to recognize, evaluate and solve problems.
• Ability to manage projects in a team environment.
• Ability to function and perform daily work independently; perform duties and tasks assigned and follow through to completion.
• Must have the ability to control emotions and maintain composure under stress, using tact and good judgment.
• Must be able to stand and walk for long periods and capable of stooping, bending, and lifting.

Working Environment

• Office based with travel to other Springfield Clinic locations (including satellite offices) and other business related travel, as required to conduct day to day business aspects of the department.

PHI/Privacy Level

• HIPAA1