Clinical Research Associate, Cardiology

About the Role

The Division of Cardiology is seeking a full-time Clinical Research Associate for an exciting, expanded role in cutting-edge research in heart failure and heart transplantation. This position is 100% supported by funding from federal and non-profit organizations, under the supervision of Dr. Palak Shah.

The Clinical Research Associate role will be responsible for managing research-related activities for multicenter clinical trials in adult and pediatric heart transplantation. Under direction of the PI, assists in performing biomedical research. This may involve recruiting subjects for studies, preparation and submission of IRB regulatory materials, preparation and submission of OSR documents, administering tests &/or questionnaires; collecting, compiling, tabulating &/or processing responses; gathering information; &/or assisting in the preparation of material for inclusion in reports.

The candidate will need to ensure that all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state, and federal laws, regulations, guidance, policy & procedure developed by the Northwestern University Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH).

This hybrid position is located on the Northwestern University Chicago Campus with one day per week remote or flexible hours. Please include a cover letter detailing relevant experience and interest with clinical research.

Working environment may include an ambulatory clinic &/or hospital setting.

Responsibilities

• Recruits research subjects for clinical studies; provides list to check in area of subjects who will be coming in that day; may bring subjects into exam rooms; Provides all necessary support during studies. May administer informed consent.
• Assists PI and other investigators in preparation and submission of IRB regulatory materials, preparation and submission of OSR documents (including consent forms), maintenance of records according to all regulations.
• Assists research coordinator in collecting, compiling, tabulating &/or processing responses; gathering information; &/or assisting in the preparation of material for inclusion in reports and journals. Assists with submission to journals.
• Assists with processing subject reimbursement materials.
• Assists PI with other mandatory regulatory and compliance areas such as CT.Gov.
• Performs other duties as assigned.

Minimum Qualifications

• Ability to successfully complete the requirements of the Northwestern Memorial Hospital Research Access Program.
• Master's degree or higher.

Minimum Competencies

• Excellent interpersonal skills
• Ability to multitask
• Technologically proficient
• Critical Thinking Skills
• Effective written and oral communicator

Preferred Qualifications

• Project Management Certification
• Doctoral degree (PhD)
• Previous experience in both observational and interventional clinical research
• CITI, GCP, HIPAA training

Preferred Competencies

• Advanced medical terminology
• Familiarity with IRB and clinical trial regulatory requirements
• Familiarity with electronic medical record systems
• Basic specimen processing skills
• Familiarity with invoicing and study financial tracking

Benefits

The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs.

Work-Life and Wellness

Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care.

Professional Growth & Development

Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources.