Coord Clinical Research Mercy Health Youngstown

Bon Secours Mercy Health•Youngstown, OH

1d•Onsite

About The Position

Mercy Health is seeking a Clinical Research Coordinator for their Youngstown location. This role is responsible for managing the research department, including coordinating current and new research trials from information gathering and contract analysis to patient enrollment and trial closure. The position involves training and supervising research staff, assisting with accreditation processes, supporting market service lines with research initiatives, and aiding associates with scholarly activities. The coordinator investigates potential trials, prepares trial information for physicians, reviews study protocols, and coordinates visits with investigators and sponsor representatives. They administer the regulatory process, manage patient scheduling, review medical histories against trial criteria, and ensure accurate data entry and monitoring. This role serves as the main contact for studies, managing equipment, supplies, and inventory. It also involves independently administering studies, including invoicing, ensuring proper reimbursement, and tracking financial documentation. The coordinator determines and implements departmental goals, such as recruitment and data entry targets, and ensures compliance with online learning requirements for staff and physicians. They prepare for monitoring visits by reviewing medical records, confirming consents, and maintaining regulatory documents. Additionally, they review safety letters and prepare notifications for family physicians. This is a full-time, 40-hour per week position with a day shift schedule.

Requirements

Associates Degree
2 years clinical experience (preferred)
Strong interpersonal skills
Proficient with spreadsheets
Proficient working with data
Must be able to organize and prioritize effectively
IATA and CITI training (must be completed once hired if not pre-employment)

Nice To Haves

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

Responsibilities

Maintain and coordinate current and new research trials.
Gather information on different trials.
Analyze and propose changes to contracts and budgets.
Maintain workflows specific to each trial.
Enroll patients.
Close out research trials.
Train, instruct, and supervise research staff.
Assist in the accreditation process for various market accreditation designations.
Support market service lines with research initiatives and data analysis.
Assist MHY associates with market-initiated scholarly activities.
Investigate potential research trials through contact with previous trail medical liaisons or sponsor companies.
Monitor clinicaltrials.gov for new possible trials.
Prepare and propose research trial information to physicians.
Review study protocols to confirm a successful outcome of the trial.
Coordinate visits with PI, CRC, and sponsor company representative.
Plan training with investigators offsite and onsite.
Administer the regulatory process in preparing the standard packet for study start-up.
Manage the scheduling of patients and determine physician involvement.
Examine patient medical history against medical trial criteria before finalizing randomization.
Record data to the appropriate site and audit research staff on data entered.
Monitor query reports regularly.
Instruct and counsel research staff with needed corrections found on query reports.
Function as the main contact for each study, reviewing emails and taking phone calls from sponsor companies.
Maintain equipment, order supplies, and manage inventory related to research.
Independently administer studies, including invoicing and knowledge of trial protocols to ensure maximum reimbursement.
Review statements to ensure proper reimbursement has been received.
Maintain a spreadsheet for each study to track invoices and reimbursement.
Determine goals as an independent research department, setting standard goals required from sponsor companies.
Implement required goals set forth from sponsor companies such as recruitment, data entry, and query resolution.
Maintain required online learning depending on the research study.
Train and educate staff on each study.
Ensure physicians and staff have completed required online learning for each study.
Prepare for monitoring visits by reviewing medical records to ensure they are complete.
Confirm that proper consents have been signed and maintain regulatory documents.
Review and confirm sign off on safety letters received by sponsors.
Prepare letters to notify family physicians of randomizations.