Research Coordinator II – Regulatory (DDI)

About the role

As a Research Coordinator II, your role is crucial in documenting data, maintaining timely reports, preparing audits, and ensuring compliance within the department. In this role, you will provide dedicated regulatory support across the DDI research portfolio, ensuring compliance, accuracy, and consistency in all regulatory processes.

Responsibilities

• Coordinate the implementation and conduct of research projects, ensuring adherence to research protocol requirements (e.g., timely completion and communication of regulatory documents, the development of data capture and monitoring plans, reporting of Serious Adverse Events, completion of Food and Drug Administration (FDA) and sponsor forms, etc.).
• Serve as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.
• Collaborate with primary investigators, sponsors and research staff to plan, conduct and evaluate project protocols, including research subject recruitment.
• Maintain regulatory binders for all active and pipeline studies.
• Serve as the primary liaison with the IRB and Compliance office, ensuring protocol adherence across all DDI studies.
• Support investigators, trainees, and coordinators with regulatory documentation and training.
• Assist with preparation for audits and response to audits.
• Assist with the development of training and educational material for assigned research protocols.
• Provide and document education as needed.
• Conduct and document the informed consent process.
• Assist with research project budget development as needed.

Requirements

• High School Diploma or GED and three years of experience as a Research Coordinator I or performing the role of a Research Coordinator I
• OR Associate's or Bachelor's degree in health care or science related and one year of experience as a Research Coordinator I or performing the role of a Research Coordinator I
• Proficient with computer-based skills such as word processing, spreadsheets, database and presentation software

Preferred qualifications

• Associate or Bachelor's degree in health care or science related field
• IRB experience

Physical Requirements

• Ability to perform work in a stationary position for extended periods
• Ability to operate a computer and other office equipment
• Ability to communicate and exchange accurate information
• In some locations, ability to move up to 25 pounds

Benefits

• Health Plan Options – You have the choice between two comprehensive Cleveland Clinic Employee Health Plan options: EHP and EHP Plus. Both plans are administered by Aetna and feature minimal copays for in-network care.
• Dental Care – Four plan options administered by Cigna are available.
• Vision Care – Two plan options administered by EyeMed are available.
• Paid Time Off (PTO) – Eligible caregivers receive Paid Time Off (PTO) that can be allotted toward vacation, holidays, sick time, etc.
• Caregiver discounts – We offer discounted rates for auto, home and pet insurance, identify theft protection and more.
• Adoption assistance – We provide financial assistance of up to $5,000/per child ($10,000 maximum lifetime benefit) for caregivers who choose to legally adopt a child.
• Employee Assistance Program – The Program provides free, confidential short-term counseling for caregivers and their families, whether for relationships or legal challenges.
• Employee Hardship Fund – This fund provides aid for caregivers experiencing unexpected financial difficulties.
• Paid maternity and parental leave – You will enjoy up to eight consecutive weeks for maternal care after the birth of your child to bond with your baby and up to four weeks for parental care.

Pay

Minimum Annual Salary: $47,530.00 Maximum Annual Salary: $72,475.00 The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate’s actual compensation will be determined after taking factors into consideration such as the candidate’s work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic’s benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).

Nursing Support Career Paths

We are committed to providing you with the resources and support you need to define and follow your own unique career path, whether in Nursing Support or other areas of our organization. Nursing Support opportunities include:

Benefits Offerings

Our caregivers deliver the best outcomes for our patients across each of our facilities. We are committed to providing them with the kind of exceptional care they bring to our patients. Caregivers like you come to work each day with a passion for what you do. So, we are always focused on fueling that passion, empowering you to be your best both inside our hospitals and in your life. Our outstanding, comprehensive offerings are an investment in your health, well-being and future. Explore the following benefits and get a closer look at how we’re focused on what matters most to you.