CLINICAL RESEARCH ASSOCIATE NCORP

Cook County Health’s Clinical Research Associate, NCORP supports patient research activities under the supervision and direction of NCORP leadership. The role coordinates clinical trial participation, monitors protocol compliance, manages research documentation and patient appointments, and protects study participants’ rights and confidentiality.

Responsibilities

Identifies eligible study patients by checking all eligibility and ineligibility criteria with the patient's medical records and approval from referring provider and principal investigator

Reviews each research study in detail to fully understand study background, requirements, patient eligibility, etc

Monitor adherence to protocols by all participating partners including physicians, nurses, physician assistants, pharmacists, and patients

Identifies any problems with protocol compliance and notifies principal investigator and/or primary provider

Resolves problems with protocol with minimum Principal Investigator involvement

Completes and submits clinical research forms (CRFs) to all necessary NCI research groups via RAVE, RedCap or other required data management system

Manage patient research activity in the electronic medical record and WebCollab, a project management tool used by the research team

Ensures that all study activity is in accordance with the guidelines, instructions and specifications outlined in the research protocol and that contractual obligation, goals and standards are met and maintained

Attends weekly tumor planning conferences

Attends working group meetings to discuss regulatory and patient updates and/or issues

Attends annual cooperative group conferences (ECOGAIRG/WF/Alliance) for protocol update and further training as discussed and agreed upon with your supervisor

Assists with coordinating clinical activities, including scheduling and rescheduling patient research appointments (i.e.: new and follow-up appointments with medical oncology, imaging, and lab appointments)

Follows up with patients who missed their clinic appointment and give them a new return date

Follows up regarding tests ordered to be sure they are scheduled appropriately

Works with others to ensure that personnel and protocols will operate within the defined research environment, with good level of cooperation with existing staff and programs

Follows procedures to protect and maintain the rights and confidentiality of all human study participants

Performs other duties assigned by NCORP leadership

Benefits

Medical, Dental, and Vision Coverage

Basic Term Life Insurance

Pension Plan

Deferred Compensation Program

Paid Holidays, Vacation, and Sick Time

You may also qualify for the Public Service Loan Forgiveness Program (PSLF)

Company

Public hospital and health care provider for Chicago

Chicago, Illinois, USA

https://cookcountyhealth.org/

Founded in 1835

1001-5000 employees

Qualifications

High School Diploma or GED equivalent required

One (1) year of experience working with clinical trial patients required

Experience and knowledge of the National Cancer Institute Community Oncology Research Program (NCORP) required

Proficiency in Microsoft Office (including Access) required

Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects (e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations)

Knowledge of the current requirements of regulatory agencies

Knowledge of clinical trials

Excellent interpersonal, verbal, written communication, and interpersonal skills necessary to communicate with all levels of staff and a patient population composed of diverse cultures and age groups

Demonstrate analytical and organizational, problem-solving, critical thinking, and conflict management/resolution skills

Ability to anticipate and plan for complex study needs, prioritize tasks, meet deadlines, and organize work

Ability to meet deadlines and help coordinate multiple aspects of the ongoing project

Required skills

NCORP, Clinical Trials, Microsoft Office, Microsoft Access, GCP/ICH Guidelines, HIPAA Regulations, Human Subjects Protection Regulations

Experience

1+ years