Clinical Research Coordinator

Good Samaritan Society; Fargo (ND); On-site; USD 33,000 - 53,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

401(k) retirement plan

Work/life balance benefits

Generous time off

Job summary

Sanford Health in Fargo, ND is hiring a Clinical Research Coordinator to learn daily and contribute to future treatments through coordinating tests, procedures, and investigational treatments in various clinical trials.

The role involves educating staff about the research process, scheduling site visits, tracking enrollment goals, and ensuring proper documentation and regulatory compliance. Local travel may be required.

Qualifications

• Bachelor's degree in biology, microbiology or related field.
• Minimum three years of clinical or clinical research experience or six to eight years of relevant work experience.
• If an LPN, currently holds an unencumbered LPN license with state nursing board and/or possess multi-state licensure privileges.

Responsibilities

• Coordinate tests, procedures, and investigational treatments for various conditions and symptoms.
• Schedule and coordinate pre-study site visits and monitor enrollment goals.
• Maintain patient screening/enrollment logs and update sponsors/CROs/SMOs.
• Ensure completion of screening, eligibility and enrollment procedures.
• Conduct interviews to assess subject ability and willingness to follow procedures.
• Prepare case report forms and ensure data accuracy and source documentation.
• Schedule sponsor monitoring visits and audits for regulatory compliance.
• Occasional local travel between sites and supervise students.

Skills

Clinical research experience

Education

Bachelors degree in biology, microbiology or related field

Licensed Practical Nurse (LPN) license (if applicable)

Job description

Careers With Purpose

Sanford Health, the largest rural health system in the United States, is dedicated to transforming the health care experience and providing access to world-class health care in America's heartland.

Facility: Sanford Broadway Med Ctr
Location: Fargo, ND
Address: 801 Broadway N, Fargo, ND 58102, USA
Shift: 8 Hours - Day Shifts
Job Schedule: Full time
Weekly Hours: 40.00
Salary Range: $24.00 - $38.50

Department Details

This position offers opportunities for learning about clinical research trials. It requires enthusiasm for learning and involvement in educating patients, physicians, nurses, and other staff about the research process. The role involves organizing complex aspects of clinical trials, including coordinating necessary tests, procedures, and investigational treatments for various conditions and symptoms.

Hours are Monday-Friday 8:00am-4:30pm. Every day is different and it is a great role for lifelong learners.

Job Summary

Provides an opportunity to learn daily and contribute to treatments of the future. Enthusiasm for learning required, along with participation in educating patients, physicians, nurses and other personnel about the research process. Organize complex components of various clinical trials, including the coordination of study-required testing and procedures, as well as investigational treatment for a variety of conditions and symptoms.

Participate in listing and clarifying questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations and study procedures.

Schedule and coordinate pre-study site visits. Monitor enrollment goals and modify recruitment plan as necessary. Maintain patient screening/enrollment logs and appropriately update sponsors, contract research organizations (CROs) and/or senior medical officers (SMOs). Assure the completion of all screening, eligibility and enrollment procedures.

Conduct interviews to assess subject ability and willingness to follow and complete study procedures and visits. Follow randomization procedures per protocol. Schedule subjects for follow-up visits. Review diaries and questionnaires completed by subjects. Ensure appropriate specimen collection, batching and shipping as required.

Collect source documents for sponsor or audit review. Assess subject compliance with the test article and follow-up visits. Abstract data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets.

Review inclusion/exclusion criteria to assure subject eligibility, and review with physician investigator for final sign-off. Review and verify required source documents in subject medical records to confirm study eligibility. Review study protocol, informed consent form and follow-up procedures with potential study subjects. Prepare case report forms for sponsor or audit review.

Responsible for insurance pre-authorization for study participation, as applicable by study. Close collaboration with physician investigators required to ensure safe and compliant investigational treatment or intervention and follow-up per the established research protocol.

Document and maintain all study-related procedures, processes and events by planning and design of new forms/source document tools to use in protocol implementation. Document protocol deviations and exemptions. Obtain and review original source documents as needed.

Record accurate and timely data onto case report forms. Maintain source documentation for all case report entries, as applicable. Key in data for electronic submission, if applicable. Correct and edit case report form entries as appropriate. Resolve data queries. Ensure drug/device accountability by completing appropriate documentations per individual protocols.

Schedule and participate in sponsor monitoring visits and audits to ensure compliance with regulatory requirements governing clinical research. Meet with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol-related issues.

Occasional local travel between sites and student supervision may be required.

Qualifications

Bachelor's degree in biology, microbiology or related field. May consider graduates of an accredited school of practical nursing as a Licensed Practical Nurse (LPN) dependent on facility and department needs.

Minimum three years of clinical or clinical research experience or six to eight years of relevant work experience required.

If a Licensed Practical Nurse (LPN), currently holds an unencumbered LPN license with state nursing board and/or possess multi-state licensure privileges. Obtains and subsequently maintains required department specific competencies and certifications.

Benefits

Sanford offers an attractive benefits package for qualifying full-time and part-time employees. Depending on eligibility, a variety of benefits include health insurance, dental insurance, vision insurance, life insurance, a 401(k) retirement plan, work/life balance benefits, and a generous time off package to maintain a healthy home-work balance. For more information about Total Rewards, visit https://sanfordcareers.com/benefits.

Sanford is an EEO/AA Employer M/F/Disability/Vet. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call 1-877-673-0854 or send an email to [e-mail].

Sanford has a Drug Free Workplace Policy. An accepted offer will require a drug screen and pre-employment background screening as a condition of employment.

Req Number: R-0271971
Job Function: Research
Featured: No