PRN Research Nurse Practitioner - Overnight, weekends, holidays

Tranquil Clinical and Research Consulting Services LLC; Texas; On-site; USD 62,000 - 90,000; Part time

Job summary

Tranquil Clinical and Research Consulting Services LLC is seeking a Part Time Research Nurse Practitioner PRN to ensure patient safety and coordinate study visits. The role operates in an office-based setting alongside the principal investigator, with responsibilities spanning protocol adherence, subject screening, and study initiation activities.

The ideal candidate holds a Nurse Practitioner credential with clinical trial experience, strong knowledge of FDA regulations and GCP, and excellent

Qualifications

• NP with related clinical experience
• Experience working on clinical trials for a minimum of 1 year
• Knowledge of FDA regulations and GCP
• Accuracy, attention to detail and ability to set priorities and meet deadlines
• Basic Computer Skills required: Microsoft Office Suite, including Word PowerPoint, Excel
• Excellent bedside manner and patient-centric focus
• Excellent time management and social skills
• Highly motivated with a phenomenal eye for detail

Responsibilities

• Coordinate and perform study visits under the supervision of the PI
• Develop management systems and prepare for study initiation
• Screen and enroll study subjects per protocol
• Manage study-related activities, subject compliance, and documentation
• Attend study-related meetings and communicate effectively with the team
• Ensure informed consent is signed and adherence to protocol guidelines

Skills

Clinical trial experience

Nurse Practitioner

FDA regulations & GCP knowledge

Attention to detail

Time management

Team collaboration

Microsoft Office Suite

Tools

Microsoft Office Suite

Job description

Job Description

Job Description

Practitioner

Tranquil Clinical Research cares about the opinion of our employees and we want the world to know what an amazing place Tranquil is to work for. We always do the right thing, our number one job is the rights, safety and well being of our patients, we train hard and we play hard. We know that our employee provides an essential service and therefore we take better care of our employees than any CRO/Phase I unit in the US

Job Title: Part Time Research Nurse Practitioner PRN

Department: Clinical Research

Reports to: CEO

Summary

The role of the study Research Nurse Practitioner is to ensure patient safety and wellbeing. The PRN Research Nurse Practitioner will coordinate and perform study visits under the guidance and supervision of the principal investigator. This is an office-based position, working in the same location as the principal investigator or in the designated clinic.

To be successful in this role, the Research Nurse Practitioner should be able to perform critical patient evaluations, in addition to recognizing logistical problems and initiating appropriate solutions. Ideal candidates will be patient-focused, detail-oriented, have the ability to multitask and be able to collaborate with various role players. The Research Nurse Practitioner must be able to work independently, be a team player, and proactively problem solve.

Qualifications

• NP with related clinical experience
• Experience working on clinical trials for a minimum of 1 year
• Knowledge of FDA regulations and GCP
• Accuracy, attention to detail and ability to set priorities and meet deadlines
• Basic Computer Skills required: Microsoft Office Suite, including Word PowerPoint, Excel
• Other Skills required:
  1. Excellent bedside manner and patient-centric focus
  2. Excellent time management and social skills
  3. Highly motivated with a phenomenal eye for detail
• Develop management systems and prepare for study initiation:
  1. Assess study feasibility in terms of study's impact on-site resources, labor cost, cost by procedure, potential for problems (such as serious AEs, noncompliance, willingness of subjects to participate, protocol deviations, etc.)
  2. Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility
  3. Review with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol
  4. Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity
  5. Develop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarity
  6. Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate.
• Screen and enroll study subjects:
  1. Review the study design and inclusion/exclusion criteria with the subject’s primary physician
  2. Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility
  3. Review the protocol, informed consent form and follow-up procedures with potential study subjects
  4. Ensure that the current approved informed consent is signed before subjects are screened and enrolled
  5. Ensure that the randomization procedure is followed as per protocol guidelines
  6. Document protocol exemptions and deviations.
• Manage study-related activities, subject compliance, and documentation:
  1. Ensure adherence to protocol requirements
  2. Schedule subjects for follow-up visits
  3. Assist investigators in assessment of subject response to therapy
  4. Review laboratory data, inform investigator of abnormal values and document
  5. Report to primary care provider as appropriate
  6. Assess and document subject compliance with medications and visits
  7. Communicate with pharmacy staff to assure timely and accurate study drug distribution
  8. Manage administration of investigational therapy
  9. Maintain dispensing logs (if allowed)
  10. Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies
  11. Oversee specimen collection, storage, and shipment
  12. Attend study-related meetings as appropriate
  13. Communicate regular... about study-rela