Coord Clinical Research Mercy Health Youngstown

Mercy Health BSMH•Youngstown, OH

About The Position

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. Mains 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. Mains 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.

Requirements

2 years clinical experience (preferred)
Strong interpersonal skills
Proficient with spreadsheets
Proficient working with data
Ability 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.
Monitor clinicaltrials.gov for new possible trials.
Prepare and propose research trial information to physicians.
Review study protocols.
Coordinate visits with PI, CRC, and sponsor company representative.
Plan training with investigators.
Administer the regulatory process for study start-up.
Manage patient scheduling.
Examine patient medical history against trial criteria.
Record data and audit research staff data entry.
Monitor query reports and instruct staff on corrections.
Act as the main contact for each study.
Maintain equipment, order supplies, and manage inventory.
Administer studies, including invoicing and reimbursement tracking.
Determine and implement departmental goals, including recruitment, data entry, and query resolution.
Maintain required online learning.
Train and educate staff on each study.
Prepare for monitoring visits.
Confirm proper consents have been signed.
Maintain regulatory documents.
Review and confirm sign-off on safety letters.
Prepare letters to notify family physicians of randomizations.