Job Category: Education and Research

Current Employees:

If you are a current employee, please apply via the internal career site by logging into your Workday Account and clicking the "Career" icon on your homepage.

Primary Location

Rapid City, SD USA

Department

RCH Research

Scheduled Weekly Hours

40

Starting Pay Rate Range

$23.25 – $29.06

(Determined by the knowledge, skills, and experience of the applicant.)

Job Summary

Clinical Research Coordinator is responsible for the full implementation and management of trials in direct collaboration with administrative and clinical leadership, investigators, sponsors and clinical research organizations. Establish and maintain effective working relationships with team members, extended health care 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 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 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 but not limited to 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

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.

Job Category

Education and Research

Job Family

Research

Shift

Employee Type

Regular

10 Monument Health Rapid City Hospital, Inc.

Make a difference.  Every day.

Monument Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Current Employees:

If you are a current employee, please apply via the internal career site by logging into your Workday Account and clicking the "Career" icon on your homepage.

Primary Work Location

Monument Health Clinical Research

Department

RCH Research

Scheduled Weekly Hours

40

Job Summary

The Clinical Research Supervisor oversees the daily operation and clinical aspects of Clinical Research Services regarding operations, clinical, and outcome performance, and facilitates a culture of improving performance to meet the needs of Monument Health and the patient. The supervisor will oversee all clinical research staff, including nursing and non-nursing staff. The supervisor works closely with the Director and demonstrates professional responsibility and accountability in collaboration with other health teams to achieve quality patient care. The supervisor may assume the role of Director of Clinical Research in his/her absence. The supervisor will utilize outcome data to monitor and control productivity and quality within the research department and provide leadership in the clinical function of the research specialties, taking an active role in assessing, planning, implementing, and evaluation of human research subject needs. He/she may provide direct or indirect care to individuals participating in clinical research protocols in collaboration with strong knowledge of and compliance with the Federal Drug Administration (FDA), International Conference on Harmonization (ICH), and Good Clinical Practice (GCP). The Clinical Research Supervisor’s duties may also include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies (sponsored, cooperative group, and investigator-initiated studies), depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain approval prior to study initiation; maintain relevant regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.

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:

• Collaborates regularly with the Director to define overall program strategy and objective.
• Consults Director for all matters regarding Clinical Research including but not limited to, selection of clinical trials and regular program Quality Reviews.
• Develops, modifies, and maintains Standard Operating Procedures for the Clinical Research Program.
• Ensures appropriate training for all involved in clinical and research staff on study protocols.
• Organizes and directs workflow of clinical research staff and coordinates while mentoring and fostering professional development and a learning environment.
• Participates in all areas of staff recruitment, performance reviews, and progressive discipline. Strategizes practice wide recruitment plans in conjunction with the Director.
• Works to ensure subject recruitment, educating clinic staff, and providers about clinical trials as well as specific Inclusion/Exclusion criteria. Works closely with Physicians, Ancillary Staff Members, and Management to improve patient care and outcomes.
• Ensures program adherence to GCP practices and study protocols.
• Protects the scientific integrity of data and protects the rights, safety and well-being of subjects.
• Plays an active role in promoting quality care and overall practice success.
• Establish and maintain professional community relationships with outside clinics/hospitals and physician/ physician offices as necessary.
• Independently manage and maintain a palette of studies with the research coordinators with minimal supervision. Ensuring studies continue to meet regulatory, GCP and institutional guidelines and processes.
• Communicate important regulatory and study related information to the Research Team, Sponsors, or regulatory authorities throughout the regulatory process.
• Maintain a working knowledge of regulations, submission requirements and processes for multiple regulatory systems.
• Adapt and adjust to changing regulations and processes while maintaining standardized regulatory operations and establishing clearly documented workflows.
• All other duties as assigned.

Additional Requirements

Required:
Education – Associates degree in Healthcare Related Field

Preferred:
Experience – 5+ years of Clinical Experience
Education – Bachelors degree in Healthcare Related Field
Certifications – 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.

Job Category

Education and Research

Job Family

Research

Shift

Employee Type

Regular

10 Monument Health Rapid City Hospital, Inc.

Make a difference.  Every day.

Monument Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.