Coord Research & Education

Mercy Health • Youngstown, OH

2d

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. Mission/Core Values: It is expected that all of the duties and responsibilities of this position will be performed in a manner consistent with the Ministry’s Standards of Behavior (CARE; Compassion: seeks to understand, listen and explain; Advocate: is the voice for the vulnerable; Respect: demonstrates the highest regard for and welcomes all people; Excellence: commits to the highest standard of quality care, joyful service, and teamwork) and in a manner that reflects the core values of Mercy Health which are: Excellence, Human Dignity, Justice, Compassion, Sacredness of Life and Service. All supervisors and above are expected to model the organizational mission and values through their daily actions, decision making and priority setting. All supervisors and above are expected to develop, implement and monitor short and long range plans to meet or surpass standards consistent with the overall strategic plan.

Requirements

• 2 years clinical experience
• Strong interpersonal skills, proficient with spreadsheets and working with data, and must be able to organize and prioritize effectively.
• Licensed Practical Nurse

Nice To Haves

• Life Science

Responsibilities

• 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. Negotiates the contract line by line. 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 medial history against medical trail criteria before finalizing the initial randomization for the trial along with retrieving physician approval. Performs initial first visit, which takes at least an hour. Administers first dose.
• 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.
• Collaborates with APEX on studies enrolled through them. 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.
• Administers a plan for an "end of study" once notification is received. This requires scheduling of last visit within an allotted time, physician needs to be onsite, review and determine if all study drugs have been returned or are accounted for, work closer with monitors to stay in line with study deadline, all data entry and queries completed, frequent onsite monitor visits, notify IRB and then box up all records according to guidelines.

Benefits

• Competitive pay, incentives, referral bonuses and 403(b) with employer contributions (when eligible)
• Medical, dental, vision, prescription coverage, HAS/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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees