JOB SUMMARY

Clinical Research Specialist is responsible for working in collaboration with the Clinical Research team and performing established clinical support for the conduct of clinical research trials. Working under the direction from leadership and the Clinical Research Coordinators to develop, implement and continue evolution of systems that ensure adherence to research protocols, institutional policies, local/state/federal regulations and “Good Clinical Practice.” Establish and maintain effective working relationships with team members, extended Healthcare providers, clinical research organizations, and regulatory agencies to ensure the safe and effective care of those who volunteer to be participants in clinical research.
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

JOB DESCRIPTION

Essential Functions:

• Assist lead CRC in developing source document templates in Microsoft Word, Excel, or similar program. Source documents should be routinely maintained to reflect accurate information that is required of sponsors by verifying against eCRF software.
• Completes relevant data collection, entry and analysis as and when needed.
• Coordinates the efforts of case finding and recruitment of study patients.
• Create, organize, submit, and maintain all pertinent study documents, records, and logs from start-up to study closure between sponsor and other offices. Documents would include regulatory documents, contracts, temperature logs, budgets, licenses, training documentation, etc.
• Creates and maintains study and subject specific case report forms. Develop data collection worksheets that ensure complete collection of data which can be accurately transmitted by data entry staff.
• Demonstrates the ability to work in collaboration with other members of the Clinical Research Team to provide safe quality care to our subject population and efficiently complete daily responsibilities which include the following:
• Develop documents and processes for successful trial implementation which are consistent with internal processes and procedures, regulatory requirements, and “Good Clinical Practice.”
• Facilitate site monitoring visits by assuring they have all the information and materials needed to effectively perform their job, assisting them while on site, close-out visit with investigator, addressing action items in monitoring letter.
• Follows study protocol in scheduling of tests, procedures, and administration of medications.
• Implement effective study-specific screening, enrollment, and follow-up processes.
• All other duties as assigned.

ADDITIONAL REQUIREMENTS

Required:
Certification - Human Subject Protection (HSP) - Collaborative Institutional Training Initiative (CITI); and Good Clinical Practice (GCP) - Collaborative Institutional Training Initiative (CITI)
Preferred:
Experience - 1+ years of Clinical Research Experience
Education - Associates degree in Health Related Field
Certification - Clinical Research Coordinator Certification - Accredited University or accredited training professionals
Physical Requirements:
Light work - Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the worker sits most of the time, the job is rated for light work.

• Assist lead CRC in developing source document templates in Microsoft Word, Excel, or similar program. Source documents should be routinely maintained to reflect accurate information that is required of sponsors by verifying against eCRF software.
• Completes relevant data collection, entry and analysis as and when needed.
• Coordinates the efforts of case finding and recruitment of study patients.
• Create, organize, submit, and maintain all pertinent study documents, records, and logs from start-up to study closure between sponsor and other offices. Documents would include regulatory documents, contracts, temperature logs, budgets, licenses, training documentation, etc.
• Creates and maintains study and subject specific case report forms. Develop data collection worksheets that ensure complete collection of data which can be accurately transmitted by data entry staff.
• Demonstrates the ability to work in collaboration with other members of the Clinical Research Team to provide safe quality care to our subject population and efficiently complete daily responsibilities which include the following:
• Develop documents and processes for successful trial implementation which are consistent with internal processes and procedures, regulatory requirements, and “Good Clinical Practice.”
• Facilitate site monitoring visits by assuring they have all the information and materials needed to effectively perform their job, assisting them while on site, close-out visit with investigator, addressing action items in monitoring letter.
• Follows study protocol in scheduling of tests, procedures, and administration of medications.
• Implement effective study-specific screening, enrollment, and follow-up processes.
• All other duties as assigned