Coord Clinical Research Mercy Health Youngstown

Mercy Health•Youngstown, OH

2d•Onsite

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. 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.

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

Responsibilities

Maintaining and coordinating current and new research trials
Gathering information on different trials
Analyzing and proposing changes to contracts and budgets
Maintaining workflows specific to each trial
Enrolling patients
Closing out research trials
Training, instructing, and supervising research staff
Assisting in the accreditation process for various market accreditation designations
Supporting market service lines with research initiatives and data analysis
Assisting MHY associates with market initiated scholarly activities
Investigating potential research trials
Monitoring clinicaltrials.gov for new possible trials
Preparing and proposing research trial information to physicians
Reviewing study protocols
Coordinating visits with PI, CRC and sponsor company representative
Planning training with investigators offsite and onsite
Administering the regulatory process in preparing the standard packet for study start up
Managing the scheduling of patients
Examining patient medical history against medical trial criteria
Recording data to appropriate site
Auditing research staff on data entered to sites
Monitoring query reports
Instructing and counseling research staff with needed corrections
Functioning as main contact for each study
Maintaining equipment, ordering supplies and managing inventory related to research
Administering studies independently, including invoicing and ensuring maximum reimbursement
Reviewing statements to ensure proper reimbursement
Maintaining spreadsheets for each study to track invoices
Determining goals for the research department
Implementing required goals set forth from sponsor companies (e.g., recruitment, data entry, query resolution)
Maintaining required online learning
Training and educating staff on each study
Preparing for monitoring visits
Confirming proper consents have been signed
Maintaining regulatory documents
Reviewing and confirming sign off on safety letters