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.
% Time
10%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.
20%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.
20%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.
10%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.
5%Maintains equipment, order supplies and manage inventory related to research.
5%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.
10�termines 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.
5%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.
5%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.
10�ministers 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.
100%Must Equal 100%.
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
Specialty/Major:Life Science
LICENSURE/CERTIFICATIONS (must be non-expired/active unless otherwise stated):
Required:Licensed Practical Nurse
Minimum Years and Type of Experience: 2 years clinical experience
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.
Other Knowledge, Skills and Abilities Preferred:
PHYSICAL DEMANDS
Please indicate the activity’s level of frequency that applies to this position using the following frequency scale:
1 = Not at all within shift (0%), 2 = Occasionally within shift (1-33%),
3 = Frequently within shift (34-66%), 4 = Continuously within shift (67-100%);
ACTIVITY
1234ACTIVITY
234ACTIVITY
Standing Climbing Crouching/ Squatting
Walking Bending Crawling
Sitting Twist at waist Kneeling
Balancing Push/Pull with force 50 lbs.
Reaching above head Reaching above shoulder Lift/Carry Up to 50 lbs.
Lift/Carry >50 lbs.]]><
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