Clinical Research Registered Nurse (RN) with Security Clearance
Job Description Clinical Research Registered Nurse (RN) Schofield Barracks, Hawaii Marathon TS is seeking a Clinical Research RN for a position at the Desmond T Doss Health Clinic, Schofield Barracks, Hawai'iThe Clinical Research Nurse will provide nursing and regulatory support and develop technology-based training/education tools as required by USAMRIID and the Desmond T Doss Health Clinic, Schofield Barracks, Hawai'iThe Clinical Research Nurse shall be trained in Good Clinical Practices and have a working knowledge of the CFR, Title 21, FDA, and the International Conference on HarmonizationOur company offers employees the opportunity to join a team where there is a robust employee benefits program, management engagement, quality leadership, an atmosphere of teamwork, recognition for performance, and promotion opportunitiesWe actively strive to channel our highly engaged employee's knowledge, critical thinking, and determination to innovate scalable solutions for our clientsResponsibilitieso Assist in Study Preparation, including developing of new clinic SOPs when required, review of research protocols, writing of informed consents, and design of Case Report Forms (CRFs).
o Perform study coordination, including scheduling of protocol-specific screening and follow-up visits and performing interval interviews and assessments at study visits for protocol-specific data.
o Maintain Complete Study Documentation, including subjects' reports and progress notes, and document protocol deviations.
o Monitor Test Article Accountability, including storage and accountability log.
o Ensure proper collection, processing and shipment of laboratory specimens collected during the studyo Assist in Recording and Reporting of Study Adverse Eventso Coordinate Study Close-Out, including sponsor/monitor closeout visito Activities will entail coordination, actual performance, guidance, monitoring and/or oversight as directed and may occur in various combinations and times depending on workload and staffing.
o Prepare Monthly Activity Reports, Screening and Volunteer Disposition logs, and Help Compile Final and Annual Reports for the Study.
o Coordinates and/or participates in the conduct of clinical research studies as a Project team member and, as directed, a team leader.
o Coordinate/perform and/or provide regulatory oversight of study activities IAW the approved protocols.
o Participate in the development of study plans and necessary infrastructure for the implementation of approved clinical studies/protocols.
o Serve as projects principle point of contact for regulatory affairs, quality assurance and clinical monitoring issues, reviews, audits, reports, etc.
o Perform as liaison between study sites as required.
o Participate in meetings and presentations related to assigned duties and/or work performed.
o May be required to provide training to staff and co-workers in planned clinical studies, GCP and other special knowledge/skills necessary for the conduct of assigned clinical studies.
o Provide training sessions to extramural sites on GCP and protocol related training.
o Provide administrative and logistics support for conduct of meetings and conferences.
o Assist the billing coordinator with invoicing regarding medical clarification for extramural and intramural research subjects within the SIP and USAMRIID.
o Maintain a safe workplace and comply with occupational health and safety rules and regulationsRequired to attend safety training(s) relative to his/her position and report any infractions of safety procedures to the Contract Program Manager and COR immediately.
o Other duties as assigned Qualificationso Have and maintain a valid unrestricted RN license in any of the U.
Sstates or territories and be able to obtain clinical privileges to practice medicine at the HCP where services are provided.
o Shall have graduated from an accredited college or university.
o Active or ability to obtain a Secret level government clearance.
o Knowledge in the areas of clinical research and regulatory affairs in matters of clinical studies, and training and education programs.
o Experience within the last three (3) years routinely practicing in rendering primary care medicine (e.
gfamily practice, general medicine, internal medicine).
o Have and maintain current Basic Life Support (BLS) certification.
o Have sufficient skills, knowledge and experience to perform the specific tasks listed for their specialtyBasic knowledge and experience in the use of word processing and spread sheetsGood written and oral communication skills as well as interpersonal skillsMust be detail oriented and take initiative.
o Provide proof of current vaccines as required by the Desmond T Doss Health Clinic, Schofield Barracks to include TB test (less than one year old and annually as required), proof of 2 MMR vaccine or titers, Varicella vaccine or titer, Tdap (within last 10 years), current Flu vaccine (and annually thereafter), and Hepatitis B vaccine or adequate titer#cjjobs Marathon TS is committed to the development of a creative, diverse and inclusive work environmentIn order to provide equal employment and advancement opportunities to all individuals, employment decisions at Marathon TS will be based on merit, qualifications, and abilitiesMarathon TS does not discriminate against any person because of race, color, creed, religion, sex, national origin, disability, age or any other characteristic protected by law (referred to as protected status ).
Recommended Skills Administration Assessments Auditing Basic Life Support Billing Case Report Forms Estimated Salary: $20 to $28 per hour based on qualifications.
o Perform study coordination, including scheduling of protocol-specific screening and follow-up visits and performing interval interviews and assessments at study visits for protocol-specific data.
o Maintain Complete Study Documentation, including subjects' reports and progress notes, and document protocol deviations.
o Monitor Test Article Accountability, including storage and accountability log.
o Ensure proper collection, processing and shipment of laboratory specimens collected during the studyo Assist in Recording and Reporting of Study Adverse Eventso Coordinate Study Close-Out, including sponsor/monitor closeout visito Activities will entail coordination, actual performance, guidance, monitoring and/or oversight as directed and may occur in various combinations and times depending on workload and staffing.
o Prepare Monthly Activity Reports, Screening and Volunteer Disposition logs, and Help Compile Final and Annual Reports for the Study.
o Coordinates and/or participates in the conduct of clinical research studies as a Project team member and, as directed, a team leader.
o Coordinate/perform and/or provide regulatory oversight of study activities IAW the approved protocols.
o Participate in the development of study plans and necessary infrastructure for the implementation of approved clinical studies/protocols.
o Serve as projects principle point of contact for regulatory affairs, quality assurance and clinical monitoring issues, reviews, audits, reports, etc.
o Perform as liaison between study sites as required.
o Participate in meetings and presentations related to assigned duties and/or work performed.
o May be required to provide training to staff and co-workers in planned clinical studies, GCP and other special knowledge/skills necessary for the conduct of assigned clinical studies.
o Provide training sessions to extramural sites on GCP and protocol related training.
o Provide administrative and logistics support for conduct of meetings and conferences.
o Assist the billing coordinator with invoicing regarding medical clarification for extramural and intramural research subjects within the SIP and USAMRIID.
o Maintain a safe workplace and comply with occupational health and safety rules and regulationsRequired to attend safety training(s) relative to his/her position and report any infractions of safety procedures to the Contract Program Manager and COR immediately.
o Other duties as assigned Qualificationso Have and maintain a valid unrestricted RN license in any of the U.
Sstates or territories and be able to obtain clinical privileges to practice medicine at the HCP where services are provided.
o Shall have graduated from an accredited college or university.
o Active or ability to obtain a Secret level government clearance.
o Knowledge in the areas of clinical research and regulatory affairs in matters of clinical studies, and training and education programs.
o Experience within the last three (3) years routinely practicing in rendering primary care medicine (e.
gfamily practice, general medicine, internal medicine).
o Have and maintain current Basic Life Support (BLS) certification.
o Have sufficient skills, knowledge and experience to perform the specific tasks listed for their specialtyBasic knowledge and experience in the use of word processing and spread sheetsGood written and oral communication skills as well as interpersonal skillsMust be detail oriented and take initiative.
o Provide proof of current vaccines as required by the Desmond T Doss Health Clinic, Schofield Barracks to include TB test (less than one year old and annually as required), proof of 2 MMR vaccine or titers, Varicella vaccine or titer, Tdap (within last 10 years), current Flu vaccine (and annually thereafter), and Hepatitis B vaccine or adequate titer#cjjobs Marathon TS is committed to the development of a creative, diverse and inclusive work environmentIn order to provide equal employment and advancement opportunities to all individuals, employment decisions at Marathon TS will be based on merit, qualifications, and abilitiesMarathon TS does not discriminate against any person because of race, color, creed, religion, sex, national origin, disability, age or any other characteristic protected by law (referred to as protected status ).
Recommended Skills Administration Assessments Auditing Basic Life Support Billing Case Report Forms Estimated Salary: $20 to $28 per hour based on qualifications.
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