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Job ID

104207

Location

Aurora

Position Type

Regular

Regular/Temporary

Regular

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Job Overview

The Nursing Clinical Research Coordinator is responsible for multiple research studies simultaneously, as a professional licensed liaison with the investigators, treating teams, pharmacy, laboratories, IRB's, Sponsors and sponsor agencies. Responsible for records and managing all phase of study protocols by sponsoring agencies ensuring compliance. Directly assists the Principal Investigator to supports the achievements of the research program and the study aims and objectives.

Additional Information:

Department: CCHRI-CCBD ClinicalHours: 40 hours/weekShift: Monday - Friday, 8am-4:30pm. Work hours may vary based on the needs of the department.

*This is a hybrid position.

Duties & Responsibilities

• Uses nursing professional knowledge to build orders in the EMR, (EPIC - Department specific).
• Makes medical assessments of study participants, within the scope of Colorado nursing practice/licensure.
• Educates clinical nursing staff, Clinical research coordinators (CRC's), and pts and families on research protocols
• Assists clinical nursing staff and CRC's in educating patients/families in regards to clinical trials and ensuring patient compliance.
• Assists clinical research coordinators (CRC's) to sign research orders within the EMR (EPIC) as required.
• Releases research orders as allowed under CHCO nursing policies
• Educates, trains and assists CRC's on an ongoing basis with nursing medical knowledge needs with regards to clinical trial requirements, complicated adverse events and Serious Adverse events (AE's and SAE's).
• Provides expertise in patient care coordination and implementation of protocol requirements during onsite visits
• Oversees the collection, data entry, and assists as needed with special procedures for study patients
• Submits and/or provides assistance to CRCs with protocol submissions to the IRB(s) for review and approval throughout startup, continuing review, amendments and correspondence process by providing necessary medical/nursing components.
• Submits and/or provides assistance to CRCs with preparation of PI applications to the FDA for eIND/IND/IDE approval.
• May write and/or assist in writing protocols, consents, and other related protocol documents from the nursing medical perspective under the direction of the principal investigator.
• Under the direction of the principal investigator assists with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs).
• Collects and disseminates information to determine feasibility, recruitment and retention strategies.
• Screens, schedules, and/or consents participants for clinical research programs and/or studies.
• Maintains subject level documentation and prepares documents, equipment and/or supplies.
• Prepares for and takes part in site initiation, monitoring, closeout visits, and document storage activities. Conducts and documents visits and testing/interviews per all regulatory and organizational protocols. Collects, prepares, processes, ships and maintains inventory of research specimens.
• Prepares study records for FDA, OHAARP, CUCC and sponsor audits.
• Employs strategies to maintain participant recruitment and retention rates and assists participants with individual needs.
• Collects, prepares and/or processes Adverse Event (AE) information per protocol and provides input for AE reports. Complete and submit AE reports, per institution and sponsor-specific reporting requirements. Maintains or collaborates to maintain appropriate documentation.
• Provides input for and assists with developing IRB related documents. Assists with identifying issues related to operational efficie cy and shares results with management.
• Maintains compliance with institutional requirements and policies. Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. May assist with the design of safeguards to ensure ethical conduct and to protect vulnerable populations.
• Participates in sponsor-required training. Obtains information for or coordinates operational plans for multiple research programs and/or studies.
• Prepares for and participates in team meetings. Proactively includes others in decision making and escalates issues to management as necessary.
• Identifies various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims. May participate in the determination of operational/statistical elements needed for conduct of clinical and translational programs and/or studies.
• Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. Recognize and report vulnerabilities related to security of physical and electronic data. Adheres to and participates in the development and assessment of quality assurance. Assists with recognizing trends related to data quality and escalates as appropriate.
• Recognize when data agreements or special regulatory requirements are necessary. May assemble the necessary parties to ensure that all requirement agreements are in place.
• Utilizes electronic data capture systems, technologies and software necessary for clinical research program and/or study operations. Scores tests, enters data and completes required forms accurately and per protocol. Assists with the development of data collection documents and instruments. Identifies issues related to data capture, collection or management and recommends solutions.
• Assists with management of Investigational Products (IP). Utilizes required system for handling, dispensing and documenting IP for sponsored protocols. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.
• Participates in monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing.
• Uses nursing professional knowledge to build orders in the EMR, (EPIC - Department specific).
• Makes medical assessments of study participants, within the scope of Colorado nursing practice/licensure.
• Educates clinical nursing staff, Clinical research coordinators (CRC's), and pts and families on research protocols
• Assists clinical nursing staff and CRC's in educating patients/families in regards to clinical trials and ensuring patient compliance.
• Assists clinical research coordinators (CRC's) to sign research orders within the EMR (EPIC) as required.
• Releases research orders as allowed under CHCO nursing policies
• Educates, trains and assists CRC's on an ongoing basis with nursing medical knowledge needs with regards to clinical trial requirements, complicated adverse events and Serious Adverse events (AE's and SAE's).
• Provides expertise in patient care coordination and implementation of protocol requirements during onsite visits
• Oversees the collection, data entry, and assists as needed with special procedures for study patients
• Submits and/or provides assistance to CRCs with protocol submissions to the IRB(s) for review and approval throughout startup, continuing review, amendments and correspondence process by providing necessary medical/nursing components.
• Submits and/or provides assistance to CRCs with preparation of PI applications to the FDA for eIND/IND/IDE approval.
• May write and/or assist in writing protocols, consents, and other related protocol documents from the nursing medical perspective under the direction of the principal investigator.
• Under the direction of th