Clinical Research Associate- Pediatrics/Family Medicine

$28.47 - $42.71 - The hourly pay rate offered is determined by a candidate's expertise and years of experience, among other factors.

• →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.

• →Education: 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
• →Experience:: Minimum 2 years' experience as a research coordinator in clinical trials research (or equivalent position) required, experience with drug and or device research preferred.
• →Experience; 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
• →Experience with EPIC and Workday preferred