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