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Our mission is clear. We bring to life a healing ministry through our compassionate care and exceptional service.
We don't believe in jobs at Mercy, we believe in careers that match the unique gifts of unique individuals; careers that not only make the most of your skills and talents, but also your heart.
At Mercy, you'll feel our supportive community every step of your day, especially the tough ones. We're a team and love working that way. That team is expanding, and we currently have exceptional opportunities to help our communities grow.
The Clinical Research Coordinator is responsible for the day-to-day operational issues related to clinical trials and performs a variety of duties including, but not limited to: volunteer recruitment, drug/device/supply inventory maintenance, interaction with physicians, nurses, office staff, patients, and clinical monitors. Duties also include the collection, compilation, documentation and analysis of clinical research data while following local, state and federal regulations. This positions will also provide professional nursing care to patients within the medical practice in support of, and as direct by, the physicians. Assists the physician in the treatment of the patients and completes related clinical paperwork.
Clinical Research Trials
1.1 Possess an in-depth understanding of each protocol that has been assigned as a primary responsibility.
1.2 Complete feasibility questionnaires in a timely fashion and with appropriate quality.
1.3 Review inclusion/exclusion criteria, overall study structure and requirements of the protocol with the Principle Investigator and clinical research manager.
1.4 Develop successful recruitment strategies to meet and exceed enrollment goals.
1.5 Familiar with and adheres to all regulatory requirements of clinical research.
2.0 Recruitment and screening of study participants.
2.1 Review the protocol, informed consent, and follow-up procedures with potential study participants.
2.2 Review and verify all relevant source documentation in the subjects' medical record to confirm eligibility.
2.3 Ensure the most current approved informed consent form is signed by the subject prior to any subject trial related procedures.
2.4 Ensure safety and welfare of study participants.
2.5 Ensure all randomization procedures are followed as per the protocol.
2.6 Documents protocol exemptions, violations, and deviations, as appropriate.
3.0 Subject follow-up procedures.
3.1 Ensure adherence to protocol requirements.
3.2 Schedule subjects for follow up visits per the protocol visit window.
3.3 Assess subject response to therapy and evaluate for adverse events.
3.4 Review laboratory data and communicate abnormal values to investigator(s).
3.5 Assess and document subject compliance with medications and visits.
3.6 Administer study drug therapy as needed and maintain the study drug dispensing logs (as legally appropriate).
3.7 Ensures appropriate specimen collection.
3.8 Attend study-related meetings as appropriate.
3.9 Communicate regularly with the Principal Investigator, Manager-Clinical Research, Director-Clinical Research, and other coordinators about study-related issues.
4.0 Case report form (CRF) preparation and study documentation.
4.1 Ensure timely and accurate CRF completion for each study subject.
4.2 Maintain source documentation for all CRF entries, including clinic chart, visit motes, lab data, and procedure reports.
4.3 Assist in providing auditors/monitors with completed CRF's, medical recoreds, lab data and other source documents for review.
5.0 Adverse experience monitoring and reporting responsibilities.
5.1 Assess and record all AE's as outlined in the protocol.
5.2 Report all serious AE's to the principal investigator, clinical research supervisor/manager and sponsor assigned monitor or appropriate designee, IRB as outlines in the protocol and primary care physician, if appropriate.
6.0 Sponsor and/or FDA audits.
6.1 Ensure that all required documentation is complete and appropriately filed.
6.2 Provide all required documentation to auditors.
6.3 Make all appropriate corrections as requested by auditors.
6.4 In case of FDA audit, make sure sponsor and all parties involved are aware of audit.
6.5 Schedule time for principal investigator and related staff to meed with auditors.Qualifications:
Because you're committed to excellence, you understand the importance of being properly prepared for your role at Mercy. That's why you'll bring to your role the right set of qualifications:
Education: Associates degree in a health or science field.
Licensure: Current LPN licensure with the Missouri State Board of Nursing or current LPN Missouri temporary work permit.
Experience: 2 years clinical or lab experience.
Certifications: Must have a current American Heart Association Healthcare Provider card or complete a course within their probation period.
Other: Skills, Knowledge, and Abilities: Must be knowledgeable and have an understanding of ICH/GCP guidelines as well as all regulatory and ethical issues governing the structure, functions, and requirements of clinical research. Incumbent needs excellent verbal and written communication skills and critical thinking skills. Must have knowledge of medical terminology and a strong familiarity with electronic medical records. Must be able to prioritize and complete multiple projects independently and efficiently with little supervision. Computer proficiency including word processing, database, spreadsheet and Internet search applications required with excellent customer service and satisfaction skills. History of meticulous attention to detail and organizational skills in all aspects of work.
We'll Support You at Work and Home
Our foundations are built on dignity and respect. Modern Healthcare Magazine named us as a “top 100 places to work.” We go out of our way to help people feel welcomed. We offer day-one comprehensive health, vision and dental coverage, PTO, and employer-matched retirement funds, even to part-time employees. We're proud to provide tuition reimbursement to help you grow and learn new skills.
What Makes a Good Match for Mercy
Compassion and professionalism go hand-in-hand with us, along with exceptional quality care. Having a positive outlook and a strong sense of advocacy is in perfect step with our mission and vision. We're also collaborative and are not afraid to do a little extra to deliver excellent care – that's just part of our commitment. If that sounds like a fit for you as well, we encourage you to apply.
Mercy has determined this is a safety-sensitive position. The ability to work in a constant state of alertness and in a safe manner is an essential function of this job.
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