Clinical Research Specialist

Monument Health is hiring a Clinical Research Specialist to support the conduct of clinical research trials in collaboration with its Clinical Research team. The role helps ensure adherence to study protocols, institutional policies, regulations, and Good Clinical Practice while supporting participant recruitment, study documentation, data collection, and trial operations.

Responsibilities

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

Preferred

Education - Associates degree in Health Related Field

Certification - Human Subject Protection (HSP) - Collaborative Institutional Training Initiative (CITI); and Good Clinical Practice (GCP) - Collaborative Institutional Training Initiative (CITI)

Experience - 1+ years of Clinical Research Experience

Associate Degree in Health-Related Field

Human Subjects Protection (HSP)

Clinical Practice (GCP)

Clinical Research Experience

Benefits

Supportive work culture

Medical, Vision and Dental Coverage

Retirement Plans

Health Savings Account

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

Flexible scheduling

Company

Integrated healthcare system in western South Dakota and eastern Wyoming

Rapid City, South Dakota, USA

https://monument.health/

Founded in 1973

1001-5000 employees

Qualifications

Education - High School Diploma/GED Equivalent

Education - Associates degree in Health Related Field

Certification - Human Subject Protection (HSP) - Collaborative Institutional Training Initiative (CITI); and Good Clinical Practice (GCP) - Collaborative Institutional Training Initiative (CITI)

Experience - 1+ years of Clinical Research Experience

Required skills

Represents the skills you have, click on the tags, Human Subject Protection (CITI)

Preferred skills

Education - Associates degree in Health Related Field, Experience - 1+ years of Clinical Research Experience

Experience

1+ years