Overview
GENERAL SUMMARY OF POSITION:
Under the general supervision of the Principal Investigator or designee the Nurse Practitioner is responsible for independently carrying out multiple complex research protocols designed to test the safety and/or efficacy of investigational drugs devices or procedures; select and monitor test populations; administer drugs (investigational or otherwise as needed); collect and analyze data; report findings to principal investigator drug company device company and IRB when necessary.
Responsibilities
MAJOR RESPONSIBILITIES:
- Administratively responsible for recruiting screening assigning maintaining and terminating study subjects
- Schedule perform and supervise all patient tests
- In conjunction with the drug manufactures protocol performs admission testing diagnostic procedures laboratory work drug administration and out-patient follow-up including procuring preparing and packaging blood specimens
- Assist in the development of SOPs
- Assist in development of research protocols case report forms and case report form completion guidelines
- Obtain patient histories and perform physical exams
- Communicate findings in a comprehensive and organized fashion verbally and in writing
- Consult with physician and monitor medication regime. Prescribe medication when necessary
- Independently makes decisions regarding patient care in absence of principal investigator
- Review new research protocols to assess for feasibility
- Act as a consultant for coordinators and principal investigators from various departments
- Assist in the design development and implementation of other research endeavors with multiple departments
- Negotiate budget and selective aspects of the clinical study agreement with the sponsoring agencies for clinical trials
- Coordinate all aspects of study protocols efficiently and in expected timeframe.
- Negotiate costs for services with laboratory/outside vendors
- Responsible for all regulatory paperwork for study initiation and continuation at UMMS (includes application for IRB informed consents etc.)
- Ensure that all federal requirements for the conduct of clinical trials are met and oversee all regulatory aspects of the research protocols
- Responsible for the formal orientation of nurses residents and attending physicians to the conduct of clinical trials
- Responsible for the budget/operational aspects ie prepare invoices for services rendered submit journal entry forms to financial services process incoming payments and prepare and maintain the budgetary records for clinical research grants
- Supervise Research Staff
- Obtain consent from patients/next of kin for participation in clinical trials
- Comply with all safety and infection control standards appropriate to this position
- Perform other job related duties as required and assigned.
Qualifications
REQUIRED QUALIFICATIONS:
- Bachelors Degree in NURSING and seven years of clinical nursing experience
- Licensed Nurse Practitioner
- Current registration in NURSING to practice in the Commonwealth of Massachusetts.
- CCRC Certification.
- GCP Training
- ACLS Certification
- Exercises knowledge of federal requirements for the conduct of clinical trials
- Certification to perform venipuncture and insert intravenous catheters
- Verbal and written communication skills necessary to interact with patients staff and outside agencies
- Visual and hearing acuity to perform patient care and literature reviews
- Experience in using computer-based tools (Word Excel Access Outlook PowerPoint etc.)
- Ability to travel to off-site locations.
Required Experience:
IC
OverviewGENERAL SUMMARY OF POSITION: Under the general supervision of the Principal Investigator or designee the Nurse Practitioner is responsible for independently carrying out multiple complex research protocols designed to test the safety and/or efficacy of investigational drugs devices or proced...
Overview
GENERAL SUMMARY OF POSITION:
Under the general supervision of the Principal Investigator or designee the Nurse Practitioner is responsible for independently carrying out multiple complex research protocols designed to test the safety and/or efficacy of investigational drugs devices or procedures; select and monitor test populations; administer drugs (investigational or otherwise as needed); collect and analyze data; report findings to principal investigator drug company device company and IRB when necessary.
Responsibilities
MAJOR RESPONSIBILITIES:
- Administratively responsible for recruiting screening assigning maintaining and terminating study subjects
- Schedule perform and supervise all patient tests
- In conjunction with the drug manufactures protocol performs admission testing diagnostic procedures laboratory work drug administration and out-patient follow-up including procuring preparing and packaging blood specimens
- Assist in the development of SOPs
- Assist in development of research protocols case report forms and case report form completion guidelines
- Obtain patient histories and perform physical exams
- Communicate findings in a comprehensive and organized fashion verbally and in writing
- Consult with physician and monitor medication regime. Prescribe medication when necessary
- Independently makes decisions regarding patient care in absence of principal investigator
- Review new research protocols to assess for feasibility
- Act as a consultant for coordinators and principal investigators from various departments
- Assist in the design development and implementation of other research endeavors with multiple departments
- Negotiate budget and selective aspects of the clinical study agreement with the sponsoring agencies for clinical trials
- Coordinate all aspects of study protocols efficiently and in expected timeframe.
- Negotiate costs for services with laboratory/outside vendors
- Responsible for all regulatory paperwork for study initiation and continuation at UMMS (includes application for IRB informed consents etc.)
- Ensure that all federal requirements for the conduct of clinical trials are met and oversee all regulatory aspects of the research protocols
- Responsible for the formal orientation of nurses residents and attending physicians to the conduct of clinical trials
- Responsible for the budget/operational aspects ie prepare invoices for services rendered submit journal entry forms to financial services process incoming payments and prepare and maintain the budgetary records for clinical research grants
- Supervise Research Staff
- Obtain consent from patients/next of kin for participation in clinical trials
- Comply with all safety and infection control standards appropriate to this position
- Perform other job related duties as required and assigned.
Qualifications
REQUIRED QUALIFICATIONS:
- Bachelors Degree in NURSING and seven years of clinical nursing experience
- Licensed Nurse Practitioner
- Current registration in NURSING to practice in the Commonwealth of Massachusetts.
- CCRC Certification.
- GCP Training
- ACLS Certification
- Exercises knowledge of federal requirements for the conduct of clinical trials
- Certification to perform venipuncture and insert intravenous catheters
- Verbal and written communication skills necessary to interact with patients staff and outside agencies
- Visual and hearing acuity to perform patient care and literature reviews
- Experience in using computer-based tools (Word Excel Access Outlook PowerPoint etc.)
- Ability to travel to off-site locations.
Required Experience:
IC
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