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Nurse Research PRN - Full-time / Part-time
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Peoria, Illinois |
About this job
Peoria Methodist Medical Ctr
FTE: 0.010000
Summary:
1. Promotes good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection, assuring compliance with protocol and regulatory requirements, and by collecting, recording, and maintaining data and source documentation.
Responsibilities:
Communicates Effectively With Subjects, Research Team, Irb, and Sponsor By:
1. Reviewing the protocol requirements with ancillary support staff (i.e. nursing, residents, pharmacist)
2. Provides education to staff on current clinical protocols and ensures adherence to study
3. Maintaining a list of sponsor/CRO contacts for each protocol
4. Providing subjects with information about reporting study-related events to research team
5. Establishing a mechanism to contact subjects for follow-up visits, new information, etc.
6. Utilizing a phone log to document telephone communications
7. Contacting primary care providers to discuss/inform of patient enrollment and study progress
8. Meeting regularly with investigator and research team to discuss subject participation and protocol progress
9. Submitting protocol amendments and progress reports to IRB in required timeframes
10. Timely notification of the investigator, sponsor, and IRB of adverse events as outlined in the protocol
11. Scheduling sponsor monitoring visit.
12. Meeting with monitors/auditors during routine visits to discuss case report form completion, query resolution, and other protocol-related issues.
13. Attending educational workshops
14. Reviewing professional publications
15. Participating in professional societies
Documents And Maintains All Study-Related Procedures, Processes, And Events By:
1. Planning and design of new forms/source document tools to be used in protocol implementation
2. Documenting protocol deviations and exemptions
3. Obtaining and reviewing original source documents (e.g., recordings, scans, tests, procedure results) as needed
4. Abstracting data from medical records, clinic, consultation, and referral notes to study forms and flow sheets
5. Recording accurate and timely data onto case report forms
6. Maintaining source documentation for all case report entries, as applicable
7. Keying data for electronic submission
8. Transmitting data via fax, mail or electronically as requested
9. Correcting and editing case report form entries as appropriate
10. Resolving data queries
11. Completing and maintaining the study article dispensing log
12. Maintaining files of all study-related documentation
13. Preparing case report forms for sponsor/audit review
14. Collecting source documents for sponsor/audit review
Participates In Protocol Assessment/Planning / Pre-Initiation Activities By
1. Applying knowledge of study design to evaluate protocol feasibility at this site
2. Assists in determining subject population availability
3. Determining equipment and facility availability
4. Assisting with a development plan for resource allocation including budget preparation, contract negotiations, and personnel needs with research coordinators oversight. 5. Following up with grants and contracts office regarding letter of agreement and indemnification
6. Listing and clarifying questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations, and study procedures
7. Developing timelines for conducting and completing the clinical protocol
8. Preparing and submitting regulatory documents to sponsor (e.g. Form FDA 1572, laboratory certification and normal values, curriculum vitae etc.)
9. Preparing and submitting institutional review board documents
10. Integrating proposed clinical trial with current research activities
11. Attending and participating in investigator meetings
12. Scheduling and coordinating pre-study site visit
13. Confirming that contact, indemnification letter, IRB approval of protocol and informed consent have been received prior to study initiation
Participates In Subject Recruitment, Enrollment, And Follow-Up Procedures By:
1. Monitoring enrollment goals and modifying recruitment plan as necessary
2. Maintaining patient screening/enrollment logs
3. Follows patient population clinically and maintains documentation supporting study
4. Reviewing inclusion/exclusion criteria with investigator to assure subject eligibility
5. Reviewing and verifying required source documents in subject's medical record to confirm study eligibility
6. Assuring that all screening, eligibility, and enrollment procedures are performed
7. Reviewing the protocol, informed consent form, and follow-up procedures with potential study subjects
8. Conducting interviews to assess the subject's ability and willingness to follow and complete study procedures and visits
9. Obtaining informed consent from research subjects prior to any study-related procedures and documenting appropriately
10. Following randomization procedures as per protocol
11. Dispensing study article as appropriate
12. Scheduling subjects for follow-up visits
13. Reviewing diaries and questionnaires completed by subject
14. Ensuring appropriate specimen collection, batching and shipping as required
15. Assessing subject compliance with the test article and follow-up visits
16. Recognizing and reporting common laboratory values and alerts to investigator and sponsor
17. Protecting patient privacy during initial and follow-up interviews
18. Securing safe storage of study-related documents
19. Assuring appropriate disposal of sensitive documents
20. Securing a permanent and safe location for all archived files
Other information:
Education:
1. Associate's Degree in the field(s) of nursing required
2. Bachelor's Degree in the field(s) of nursing or related preferred
Credentials:
1. Registered Nurse in the state of IL
2. Valid Driver's License in the state of IL
Experience:
1. 1-3 years of experience in/with effective delegation as well as give direction and guidance preferred.
EOE M/F/V/D
FTE: 0.010000
Summary:
1. Promotes good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection, assuring compliance with protocol and regulatory requirements, and by collecting, recording, and maintaining data and source documentation.
Responsibilities:
Communicates Effectively With Subjects, Research Team, Irb, and Sponsor By:
1. Reviewing the protocol requirements with ancillary support staff (i.e. nursing, residents, pharmacist)
2. Provides education to staff on current clinical protocols and ensures adherence to study
3. Maintaining a list of sponsor/CRO contacts for each protocol
4. Providing subjects with information about reporting study-related events to research team
5. Establishing a mechanism to contact subjects for follow-up visits, new information, etc.
6. Utilizing a phone log to document telephone communications
7. Contacting primary care providers to discuss/inform of patient enrollment and study progress
8. Meeting regularly with investigator and research team to discuss subject participation and protocol progress
9. Submitting protocol amendments and progress reports to IRB in required timeframes
10. Timely notification of the investigator, sponsor, and IRB of adverse events as outlined in the protocol
11. Scheduling sponsor monitoring visit.
12. Meeting with monitors/auditors during routine visits to discuss case report form completion, query resolution, and other protocol-related issues.
13. Attending educational workshops
14. Reviewing professional publications
15. Participating in professional societies
Documents And Maintains All Study-Related Procedures, Processes, And Events By:
1. Planning and design of new forms/source document tools to be used in protocol implementation
2. Documenting protocol deviations and exemptions
3. Obtaining and reviewing original source documents (e.g., recordings, scans, tests, procedure results) as needed
4. Abstracting data from medical records, clinic, consultation, and referral notes to study forms and flow sheets
5. Recording accurate and timely data onto case report forms
6. Maintaining source documentation for all case report entries, as applicable
7. Keying data for electronic submission
8. Transmitting data via fax, mail or electronically as requested
9. Correcting and editing case report form entries as appropriate
10. Resolving data queries
11. Completing and maintaining the study article dispensing log
12. Maintaining files of all study-related documentation
13. Preparing case report forms for sponsor/audit review
14. Collecting source documents for sponsor/audit review
Participates In Protocol Assessment/Planning / Pre-Initiation Activities By
1. Applying knowledge of study design to evaluate protocol feasibility at this site
2. Assists in determining subject population availability
3. Determining equipment and facility availability
4. Assisting with a development plan for resource allocation including budget preparation, contract negotiations, and personnel needs with research coordinators oversight. 5. Following up with grants and contracts office regarding letter of agreement and indemnification
6. Listing and clarifying questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations, and study procedures
7. Developing timelines for conducting and completing the clinical protocol
8. Preparing and submitting regulatory documents to sponsor (e.g. Form FDA 1572, laboratory certification and normal values, curriculum vitae etc.)
9. Preparing and submitting institutional review board documents
10. Integrating proposed clinical trial with current research activities
11. Attending and participating in investigator meetings
12. Scheduling and coordinating pre-study site visit
13. Confirming that contact, indemnification letter, IRB approval of protocol and informed consent have been received prior to study initiation
Participates In Subject Recruitment, Enrollment, And Follow-Up Procedures By:
1. Monitoring enrollment goals and modifying recruitment plan as necessary
2. Maintaining patient screening/enrollment logs
3. Follows patient population clinically and maintains documentation supporting study
4. Reviewing inclusion/exclusion criteria with investigator to assure subject eligibility
5. Reviewing and verifying required source documents in subject's medical record to confirm study eligibility
6. Assuring that all screening, eligibility, and enrollment procedures are performed
7. Reviewing the protocol, informed consent form, and follow-up procedures with potential study subjects
8. Conducting interviews to assess the subject's ability and willingness to follow and complete study procedures and visits
9. Obtaining informed consent from research subjects prior to any study-related procedures and documenting appropriately
10. Following randomization procedures as per protocol
11. Dispensing study article as appropriate
12. Scheduling subjects for follow-up visits
13. Reviewing diaries and questionnaires completed by subject
14. Ensuring appropriate specimen collection, batching and shipping as required
15. Assessing subject compliance with the test article and follow-up visits
16. Recognizing and reporting common laboratory values and alerts to investigator and sponsor
17. Protecting patient privacy during initial and follow-up interviews
18. Securing safe storage of study-related documents
19. Assuring appropriate disposal of sensitive documents
20. Securing a permanent and safe location for all archived files
Other information:
Education:
1. Associate's Degree in the field(s) of nursing required
2. Bachelor's Degree in the field(s) of nursing or related preferred
Credentials:
1. Registered Nurse in the state of IL
2. Valid Driver's License in the state of IL
Experience:
1. 1-3 years of experience in/with effective delegation as well as give direction and guidance preferred.
EOE M/F/V/D
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