Coord Clinical Research Mercy Health Youngstown

• Accountable for the research department in maintaining and coordinating current and new research trials from gathering information on different trials, analyzes and proposes changes to the contracts and budgets, maintaining workflows specific to each trial, enrolling patients, to the close of each research trial. This includes training, instructing, and supervising research staff. 
• Assists in the accreditation process for various market accreditation designations.
• Supports market service lines with research initiatives and data analysis as needed.
• Assists MHY associates with market initiated scholarly activities.
• Investigates potential research trials through contact with previous trail medical liaisons, or is contacted by previous sponsor companies, and monitors clinical trials.gov for new possible trials that would be of interest to the physicians within the specialty or beneficial to the research department.
• Prepares and proposes the research trial information to physicians. Reviews study protocols to confirm a successful outcome of the trial. Coordinates visits with PI, CRC and sponsor company representative.
• Plans training with investigators offsite and onsite.
• Administers the regulatory process in preparing the standard packet for the study start up
• Manages the scheduling of patients and determines if the physician needs to be in office or if it will be a visit with research staff.
• Examines all patient medical history against medical trail criteria before finalizing the initial randomization for the trial along with retrieving physician approval.
• Records data to appropriate site and audits research staff on data entered to sites is accurate. Monitors query reports regularly and can monitor them at any time through each site. Instructs and counsels research staff with needed corrections found on the query reports.
• Functions as main contact for each study, which includes reviewing emails and taking phone calls from a sponsor company and furnishes them with the information needed or requested.
• Maintains equipment, order supplies and manage inventory related to research.
• Independently administer studies, which requires invoicing and knowledge of trial protocols to ensure maximum reimbursement for each study, reviewing statements to ensure proper reimbursement has been received, maintain a spreadsheet for each study to track invoices and this helps with documentation of reimbursement that is expected if asked by one of the physicians.
• Determines goals as an independent research department, such as setting standard goals required from sponsor company to ensure success and daily goals depending on the sponsors requests due to lists of information needed at different dates. Implements required goals set forth from sponsor companies such as recruitment, data entry and query resolution.
• Maintains required online learning depending on the research study. Train and educate staff on each study and ensure physicians and staff has completed required online learning for each study.
• Prepares for monitoring visits by reviewing medical records to ensure they are complete. Confirm that proper consents have been signed and maintain regulatory documents needed for each studies requirements. Review and confirm sign off on safety letters received by sponsors. Prepare letters to notify family physicians of randomizations.

The above is intended to describe the general content and functions of this job. It is not to be construed as an exhaustive list of all duties or responsibilities. Employees may be required to perform other job related duties as required by their supervisor, subject to reasonable accommodation. The job description is subject to continual revisions as needed for patient care. Due to the services and care provided by this institution, personnel may be requested to serve in related capacities as determined by their qualifications in a different unit, department, and campus, in an effort to not disrupt patient care and continue to provide a safe environment to our patients. All employees are expected to follow Mercy Health policies and procedures, maintain high standards of safe work performance, and maintain good attendance and punctuality.

MINIMUM EDUCATION Required Minimum Education: Specialty/Major: Associates Degree Preferred Education:Specialty/Major: Bachelors degree or equivalent in physical sciences, epidemiology, biostatistics, or related field Combination of post-secondary education and experience will be considered in lieu of degree. LICENSURE/CERTIFICATIONS (must be non-expired/active unless otherwise stated): None IATA and CITI training are required. If not completed pre-employment, these must be completed once hired.

MINIMUM QUALIFICATIONS

·Minimum Years and Type of Experience: 2 years clinical experience (preferred)

·Other Knowledge, Skills and Abilities Required: Strong interpersonal skills, proficient with spreadsheets and working with data, and must be able to organize and prioritize effectively.

As a Bon Secours Mercy Health associate, you're part of a Mission that matters. We support your well-being—personally and professionally. Our benefits are built to grow with you and meet your unique needs, every step of the way.

What we offer

• Competitive pay, incentives, referral bonuses and 403(b) with employer contributions (when eligible)
• Medical, dental, vision, prescription coverage, HSA/FSA options, life insurance, mental health resources and discounts
• Paid time off, parental and FMLA leave, short- and long-term disability, backup care for children and elders
• Tuition assistance, professional development and continuing education support

Benefits may vary based on the market and employment status.

All applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, genetic information, or protected veteran status, and will not be discriminated against on the basis of disability. If you'd like to view a copy of the affirmative action plan or policy statement for Bon secours Mercy Health – Youngstown, Ohio or Bon Secours – Franklin, Virginia; Petersburg, Virginia; and Emporia, Virginia, which are Affirmative Action and Equal Opportunity Employers, please email [email protected]. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact The Talent Acquisition Team at [email protected]