Research Nurse

Job Description

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.

Tranquil Clinical Research offers employees competitive pay for all positions. Employee benefits are paid in full including Medical, Dental, Vision, LTD and STD and Life Insurance policies. Each employee receives 16 days of PTO and 6 days of sick/mental health days with all of the major holidays off.

Job Title: Research Nurse/Research Coordinator/Clinical Study Coordinator

Department: Clinical Research

Reports to: CEO

Summary

The role of the study Research Nurse is to ensure patient safety and wellbeing. TheResearch Nurse 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 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 must be able to work independently, be a team player, and proactively problem solve.

Qualifications

RN/LVN 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:

Excellent bedside manner and patient-centric focus

Excellent time management and social skills

Highly motivated with a phenomenal eye for detail

Develop management systems and prepare for study initiation:

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.)

Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility

Review with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol

Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity

Develop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarity

Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate.

Screen and enroll study subjects:

Review the study design and inclusion/exclusion criteria with the subject’s primary physician

Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility

Review the protocol, informed consent form and follow-up procedures with potential study subjects

Ensure that the current approved informed consent is signed before subjects are screened and enrolled

Ensure that the randomization procedure is followed as per protocol guidelines

Document protocol exemptions and deviations.

Manage study-related activities, subject compliance, and documentation:

Ensure adherence to protocol requirements

Schedule subjects for follow-up visits

Assist investigators in assessment of subject response to therapy

Review laboratory data, inform investigator of abnormal values and document

Report to primary care provider as appropriate

Assess and document subject compliance with medications and visits

Communicate with pharmacy staff to assure timely and accurate study drug distribution

Manage administration of investigational therapy

Maintain dispensing logs (if allowed)

Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies

Oversee specimen collection, storage, and shipment

Attend study-related meetings as appropriate

Communicate regularly with the principal investigator, monitor (and others responsible for conduct of the research) about study-related issues.

Record data and study documentation:

Record data as directed using the appropriate media or platform

Follow procedures for access and security for electronic data entry

Review keyed data for accuracy, as needed

Send data to the data collection center on a timely basis

Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports

Correct and edit data as directed and as appropriate.

Monitor and report adverse events:

Assess, document and record all AEs as outlined in the protocol

Report serious AEs o the Principal Investigator, Sponsor and IRB (and others as required by funding source or as outlined in the protocol).

Regulatory documentation:

Know and understand all regulatory requirements associated with the conduct of the study assigned

Maintain files and documents as regulations dictate

Prepare and submit initial applications to central and local committees (IRBs, biosafety, radiology, etc.), prepare and submit reports, as required

Ensure that all required documentation is complete and appropriately filed.

Management of site activities during audits and inspections:

Prepare for quality assurance audits and regulatory inspections, as needed

Act as contact person before, during and after audits and inspections

Provide all required documentation to auditors

Make all appropriate corrections as requested by auditors

Coordinate site response to audit/inspection findings.

Management of ancillary staff:

Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).

Full-time