Clinical Research Coordinator I

The Medical College of Wisconsin, Inc.; Wauwatosa (WI); On-site; USD 52,000 - 80,000; Full time

Benefits offered by this job

Health insurance

Paid holidays

Tuition reimbursement

Onsite fitness facility

Job summary

The Medical College of Wisconsin, Inc. seeks a program administrator to support the daily operations of the clinical trials program in collaboration with the Children’s Hospital of Wisconsin.

This role involves coordinating with Principal Investigators, maintaining study documentation, and ensuring regulatory compliance across IRB and GCP standards. You will assist in data collection, analysis, and reporting, while supporting outreach and materials development for trial activities.

Qualifications

• Experience supporting clinical trials or research coordination is preferred.
• Familiarity with regulatory requirements (IRB, GCP) and study documentation best practices.
• Ability to manage documentation, deadlines and data integrity.

Responsibilities

• Support day-to-day administration of the clinical trials program.
• Coordinate trial activities with Principal Investigators and hospitals.
• Screen, enroll, and consent study participants as applicable.
• Maintain data collection, entry, and reporting for studies.
• Ensure regulatory compliance and training/updating certifications.
• Assist in IRB submissions and protocol development.

Skills

IRB compliance

GCP training

EMR EPIC

OnCore familiarity

Data analysis

Documentation

Communication

Education

Associate's Degree

Tools

OnCore

EPIC

MS Office

Job description

SummaryPerform the day-to-day administrative activities of the clinical research trials program. Provide support to the team to facilitate the achievement of the program’s goals.Primary ResponsibilitiesWorking with multiple Principal Investigators ensure proper conduct of assigned Clinical Trials Office trials, Children’s Hospital of Wisconsin. Maintain regular contact and provide updates whenever necessaryWork closely with CTO leads/managers on a day-to-day basis providing updates and managing priorities.Screen, recruit, enroll and obtain consent from study participants.Coordinate research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants.Collect, analyze, and disseminate study data. Report data and progress to PIs and CTSI stakeholders.Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators.Assure compliance with all relevant IRB, HIPAA, GCP and other regulatory requirements. Responsible for maintaining ongoing training, certifications and compliance with current regulations at MCW, CHW and VA.Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.Collaborate on the development of study materials including educational materials, marketing materials, websites, forms, and reports.Work with Principal Investigator to develop, implement, and maintain comprehensive databases and files related to the program.Maintain program timeline including tracking deadlines for program components.Coordinate program outreach activities including acting as a liaison with community organizations.Process and ship lab specimens as necessary. IATA certification to be obtained within 30 days of hire.Familiarity with EMR (EPIC) preferred.Display familiarity in utilization of clinical trial management systems, proficiency with OnCore preferred.Knowledge – Skills – AbilitiesKnowledge of biology, chemistry, mathematics, documentation, and records management.Data utilization, complex problem solving, critical thinking, resource management, and writing skills.QualificationsAppropriate experience may be substituted for education on an equivalent basis.Minimum Required Education: Associate's DegreeMinimum Required Experience: 1 yearRequired Certification/Licensure(s): CITI and GCP training within 90 days of hirePhysical RequirementsWork requires occasionally lifting moderate weight materials, standing, or walking continuously.Work EnvironmentOccasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.Sensory AcuityAbility to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.Why MCW?Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options403B Retirement PackageCompetitive Vacation and Paid Holidays offeredTuition ReimbursementPaid Parental LeaveEmployee & Family Assistance Program (EFAP)Pet InsuranceOn campus Fitness Facility, offering onsite classesAdditional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.For a brief overview of our benefits see: Benefits OverviewFor a full list of positions see: MCW CareersAt MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring – Collaborative – Curiosity – Inclusive – Integrity – Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you. For more information, please visit our institutional website.MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination:The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.