Job Title: Clinical Research Associate - Research Affairs
Department: Office of Research Affairs (ORA)
Shift: 1st
Specialty: Research
Job Number: 2022-3531
Date Posted: 08/19/2022
Position Type: Research

Job Qualifications:

Clinical Research Associate

The Clinical Research Associate (CRA) is responsible for serving as an internal monitor with Good Clinical Practice, FDA regulations, and OHRP guidelines on clinical trials that are not currently monitored or have deficiencies in monitoring. The CRA creates and reviews source documents, case report forms, drug accountability logs, and regulatory binders (whether on paper or electronic) to ensure they are accurate, complete, and consistent in accordance with national and international guidelines. The CRA must be familiar with current FDA regulations, current Cancer Therapy Evaluation Program (CTEP) guidelines, and SOPs for clinical research, as well as be able to advise on effective Corrective and Preventive Action (CAPA) plans for potential external collaborators. The individual who holds this position exemplifies the Rush mission, vision, and values and acts in accordance with Rush policies and procedures.

Job Responsibilities:

• Assists Principal Investigators (PIs) and research teams with investigator-initiated research.
• Provides input on the protocol design, implementation, and monitoring plan for clinical trials.
• Assists in the preparation of Investigational New Drug (IND) Applications, periodic reports, New Drug Applications (NDAs), and Biological License Applications (BLAs).
• Provides input and may assist in creation of case report forms and advises on RedCap database creation.
• Assists Coordinators in all aspects of the study including recruitment, consent, screening, scheduling, and tracking and provides study updates to study participants throughout the duration of the study.
• Interfaces with external collaborators (other study sites) in all aspects outlined above.
• Monitors clinical trials for protocol adherence, adherence to federal regulations (NCI, NIH), FDA regulations, and departmental SOPs.
• Monitors external sites, which may include travel to those sites.
• Monitors investigator/physician adherence to protocols, departmental SOPs, FDA regulations, IRB policies, OHRP guidelines, and/or CTEP guidelines.
• Addresses enrollment challenges and advises on corrective actions.
• Identifies key areas of non-compliance in partnership with Research Compliance. Advises on strategy to render the non-compliance or lack of competency.
• Sets up study centers, as in conducting Site Initiation Visits (SIVs), Close-Out Visits (COVs), monitoring visits, and audits; ensures each center has the appropriate trial materials. May travel offsite to these alternate sites that are affiliated with Rush or identified as additional sites or satellite sites.
• Visits the study centers internally and externally throughout the trial on a regular basis to monitor data quality, date integrity, and protocol compliance.
• Ensures the patient data in the case report forms (CRFs) or electronic data capture (EDC) system is accurate and matches source documentation.
• Validates and collects completed CRFs from all sites, including hospitals and general practices, if applicable.
• Coordinates DSMB reports and may create the submission to the DSMB. Compiles all the necessary data and creating the appropriate report for the DSMB. Disseminates the DSMB report outcomes internally and to other study sites.
• May interface with the FDA for required submissions as well as advise the PI and study teams on those submissions or submit on behalf of the study.
• Closes down study centers upon completion of trial in accordance with FDA regulations.
• Writes up monitoring, auditing or FDA reports as needed, and follows-up on completion of all outstanding tasks.
• Contributes to CAPA plans as necessary. May assist in writing CAPAs as needed.
• Ensures the conduct of the trial is in compliance with the current IRB approved protocol/amendment.
• Verifies that the investigator followed the IRB approved protocol and all GCP procedures, FDA regulations, institutional policies and SOPs.
• Works with management to ensure that personnel and projects operate within the defined research environment with acceptable levels of cooperation with existing staff and programs.
• Follows procedures to protect and maintain the rights and confidentiality of all human study participants.
• Performs related duties as required.

Required Job Qualifications:

• Bachelor's degree required and five years of clinical research experience required; OR nine years of clinical research experience.
• Certification from a recognized professional organization (i.e., Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP) is required.
• Previous experience preparing and conducting monitoring visits.
• Investigator-initiated trial experience required.
• Broad knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical trials required. Proficiency with Microsoft Office Suite required.
• Travel may be required.
• Excellent written and verbal communication skills.
• Strong interpersonal, organizational, and problem-solving skills.
• Proven ability to exercise independent judgment and ability to use critical thinking to analyze problems that may require multiple factors and approaches.
• Must be flexible and comfortable working in fast-paced environments.
• Ability to demonstrate resourcefulness and attention to detail.

Preferred Job Qualifications:

• Master's degree preferred.
• Clinical trial monitoring experience preferred.
• Background in Hematology/Oncology trials is preferred.
• Complex/early phase trial management experience preferred.

Company Highlights:
Ranked among the top academic medical centers in the country, Rush University Medical Center is an outstanding place to enhance your career. Everything we do centers on one goal: improving patient care.
The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has awarded Rush full accreditation for three years. Rush is one of the first academic medical centers in Illinois to receive this accreditation.
As an academic medical center, Rush University Medical Center in Chicago, Illinois, is committed to advancing medical knowledge through research. Investigators at Rush are involved in more than 1,600 projects, including hundreds of clinical studies to test the effectiveness and safety of new therapies and medical devices, as well as to expand scientific and medical knowledge.
RUMC offers a competitive salary, outstanding benefits & the professional advantages of an environment that supports your development & recognizes your achievements.
Rush University is home to one of the first medical colleges in the Midwest and one of the nation's top-ranked nursing colleges, as well as graduate programs in allied health, health systems management and biomedical research.

Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics