Clinical Research Associate- Pediatrics/Family Medicine

Endeavor Health•Evanston, IL

8d•Onsite

About The Position

Endeavor Health’s department of Pediatrics and department of Family Medicine is seeking applicants for Clinical Research Associate (CRA). Primary responsibility for this position is the management and oversight of several research projects (possibly involving multiple data collection sites) involving human subjects, particularly medical patients. The CRA provides support to the Research Manager, CRU director, Physicians, and Research Scientists in the Departments of Pediatrics and Family Medicine. The CRA assists in consenting of patients to research studies, IRB processing and compliance with federal, state, local, and institutional research regulations, writing grants for submission to external funding agencies. Manages all aspects of interactions with the Endeavor Health IRB for designated/assigned projects. This position is responsible for administering the processes and procedures necessary to ensure compliance with the requirements of the Endeavor Health IRB and external funding agencies such as budget management, progress reports, and protocol revisions. The duties of this position are typically performed in coordination with study investigators to plan and implement new research projects, assistance with design of data collection and tracking forms, development and implementation of data tracking procedures, coordination and liaison with other research sites, training and oversight of data collection personnel, monitoring quality assurance for data collection, management of study databases with assistance from programmers and statisticians, and production of data reports for tracking purposes. This position will involve subject recruitment, data collection, and the performance of other research project-related tasks, as needed.

Requirements

Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as biology, social, or health science or related
Minimum 2 years' experience as a research coordinator in clinical trials research (or equivalent position) required
Experience with drug and or device research preferred.
Facilitating recruitment and follow up strategies with clinic personnel and operational problem solving
Proficient knowledge of FDA, HSR, and GCP guidelines
Excellent organization, time management, problem solving and communication (both written and verbal) skills
Ability to interact in a professional and sensitive manner with medical personnel, research subjects, research collaborators, community groups and other research staff
Must be able to work independently or with minimal supervision, and show initiative

Nice To Haves

Experience with EPIC and Workday preferred

Responsibilities

Ensure compliance with applicable federal, state, local, IRB, and Good Clinical Practice (GCP) regulations.
Support all aspects of human-subject clinical research across Pediatrics and Family Medicine.
Collaborate with Research Managers, Principal Investigators (PIs), Research Scientists, sponsors, and national/international collaborators.
Evaluate the feasibility, resources, timelines, and financial requirements of proposed studies.
Develop, adapt, and maintain research protocols, consent forms, study documents, and regulatory materials.
Prepare and submit IRB applications, amendments, renewals, adverse events, progress reports, and responses.
Ensure research staff maintain required human-subject training and certifications.
Recruit, screen, enroll, and consent study participants; determine eligibility and perform randomization as required.
Coordinate and assist with study visits, patient care, scheduling, and protocol procedures.
Maintain communication with participants and provide education and resources to support protocol compliance.
Coordinate specimen collection, processing, storage, and shipment, including blood, urine, and tissue samples.
Retrieve, collect, enter, and maintain research data and subject records; ensure accuracy and completeness of case report forms and source documents.
Manage study files, databases, supplies, payments, equipment, test articles, and document retention.
Monitor study progress, expenditures, accounts, timelines, adverse events, and protocol compliance.
Prepare for and support monitoring visits, audits, and study closeout activities.
Assist with research study design, database development, data collection strategies, and analysis.
Conduct literature reviews and support preparation of protocols, manuscripts, abstracts, presentations, posters, and publications.
Coordinate and support grant submissions, including budgets, CVs, biosketches, supporting documents, and funding opportunities.
Develop and maintain research databases, websites, procedure manuals, and study-related resources.
Create study advertisements and communications in collaboration with marketing/public relations.
Participate in research meetings, conferences, and departmental initiatives.
Provide supervision, training, and orientation to research staff as needed.
Perform other research-related duties and projects as assigned by the Research Manager.

Benefits

Eligibility for our Annual Incentive Plan, which offers the potential to earn a certain percentage amount of your base salary based on organizational performance.
Premium pay such as shift, on call, holiday and more based on an employee’s job
Incentive pay for select positions
Opportunity for annual increases based on performance
Career Pathways to Promote Professional Growth and Development
Various Medical, Dental, Pet and Vision options
Tuition Reimbursement
Free Parking
Wellness Program
Savings Plan
Health Savings Account Options
Retirement Options with Company Match
Paid Time Off and Holiday Pay
Community Involvement Opportunities