Clinical Research Coordinator

at  Monument Health

JOB SUMMARY

The hospital based Clinical Research Coordinator affords an opportunity to learn daily and contribute to treatments of the future. Enthusiasm for learning is required, along with participation in educating patients, physicians, nurses and other personnel to the research process. Advanced coordinator position that involves clinical patient contact, research study coordination and study data management. Must be able to organize complex components of clinical trials, including test ordering, procedure scheduling and insurance pre-authorization for participants, if applicable.
Clarify questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations and study procedures. Review inclusion/exclusion criteria to assure subject eligibility and review with physician investigator. Review study protocol, informed consent form and follow-up procedures with potential study subjects.
Schedule subjects for follow-up visits to review diaries and questionnaires. Ensure appropriate specimen collection, batching and shipping as required. Document and maintain all study-related procedures, processes and events. Document protocol deviations and exemptions and record accurate and timely data. Maintain accurate source documentation for all case report entries and input data for submission.
Required to use appropriate coordinator assessment skills to evaluate patient condition in response to study intervention/study protocol. Collect data regarding patient condition for review by the physician investigator. Travel between clinic and hospital for patient care.
Monument Health offers competitive wages and benefits on qualifying positions. Some of those benefits can include:
*Supportive work culture
*Medical, Vision and Dental Coverage
*Retirement Plans, Health Savings Account, and Flexible Spending Account
*Instant pay is available for qualifying positions
*Paid Time Off Accrual Bank
*Opportunities for growth and advancement
*Tuition assistance/reimbursement
*Excellent pay differentials on qualifying positions (extra pay for working evening, nights or weekends)
*Flexible scheduling

ADDITIONAL REQUIREMENTS

Required:
Certification - Human Subject Protection (HSP) - Collaborative Institutional Training Initiative (CITI); and Good Clinical Practice (GCP) - Collaborative Institutional Training Initiative (CITI)
Preferred:
Education - Bachelors degree in Healthcare
Experience - 3+ years of Healthcare Experience
Certification - Clinical Research Coordinator Certification - Accredited University or accredited training professionals
Physical Requirements:
Sedentary work - Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

• Assist investigator in assessment of subject response to therapy.
• Review Laboratory data, inform investigator of abnormal values and document, report to primary care provider as appropriate.
• Assess and document subject compliance with medications and visits.
• Maintain administration and documentation for dispensing of investigational products and/or study-related supplies.
• Maintain source documentation for all data entered, including clinic chart visit notes, lab data, and procedure reports.
• Correct and edit data as directed as appropriate.
• Monitor, assess, document and record all AEs as outlined in protocol.
• Report serious AEs to the Principal Investigator, sponsor, and IRB (and other responsible for conduct of the research) about study-related issues.
• Vital sign measurement and documentation.
• Perform EKGs.
• Training of research staff in appropriate roles.
• Attend study-related meetings as appropriate.
• Upload echo and CT images per study requirements in study portals.
• Facilitate training of the appropriate hospital staff (Echo and CT techs) on protocol specific tests.
• Pre-Screen In-Patient Population
• Follow-up activities/visits on certain trials
• Time Sensitive Enrollments and Cath Labs Cases at the Hospital
• All other duties as assigned.