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About The Position

Requirements

• Bachelor’s degree and one year research experience required.
• A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job.
• Proficient organizational skills with ability to manage multiple studies.
• Proficient verbal and written communications skills.
• Proficient knowledge of FDA, HSR, and GCP Guidelines.
• Proficient analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems.
• Proficient entry level leadership skills.
• Recognizes the need to prioritize tasks, problem solve, and work with others.
• Assists to foster an inclusive environment where all team members feel valued and respected.

Responsibilities

• Manages research projects, including study start-up, protocol coordination, monitoring, and close-out activities.
• Maintains strict adherence to study protocols and regulatory standards throughout all phases of the study.
• Manages study regulatory activities by preparing and maintaining all regulatory documents and regulatory agencies, including protocols, informed consent documents, recruitment materials, initial submissions, modifications, and renewals.
• Maintains comprehensive study documentation such as regulatory binders and correspondence.
• Coordinates the conduct of behavioral research projects with various departments, adheres to standard operating procedures (SOPs) to ensure adherence to research protocols and regulatory standards, and track deadlines for grants and deliverables.
• Identifies and recruits eligible study subjects, manage the informed consent/assent process, coordinate the reimbursement of study participants, and serve as the primary liaison for participant inquiries.
• Arranges and conducts research visits, including delivering behavioral interventions, such as administering surveys, facilitating interviews, and leading focus groups.
• Abstracts and enters data from medical records onto protocol-specific case report forms and electronic systems, record data on source documents and CRFs, and conduct statistical analysis under PI supervision.
• Conducts quality assurance activities by adhering to research protocols and applicable regulations (OHRP, FDA, GCP), performing QA/QC checks for database validity, and ensuring ongoing data monitoring to maintain high standards of research integrity.
• Attends research meetings and actively participate in educational conferences to promote the ethical conduct of research and stay informed about best practices.
• Participates in the preparation and presentation of research findings through abstract and poster development and assists in the writing and editing manuscripts.
• Other job functions as assigned.

Benefits

• Medical, dental and vision insurance
• Employer paid group term life and disability
• Employer contribution toward Health Savings Account
• Flexible Spending Accounts
• Paid Time Off (PTO), Paid Holidays and Paid Parental Leave
• 403(b) with a 5% employer match
• Various voluntary benefits: Supplemental Life, AD&D and Disability
• Critical Illness, Accident and Hospital Indemnity coverage
• Tuition assistance
• Student loan servicing and support
• Adoption benefits
• Backup Childcare and Eldercare
• Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members
• Discount on services at Lurie Children’s facilities
• Discount purchasing program