Freelance Clinical Research Protocol Writer Jobs

Job Description:

The Clinical Research Nurse will be able to function as a Clinical Research Coordinator and shall assist primary investigators with the following tasks in order to develop institutionally‐approved research protocols:

• Identify the appropriate forms and processes necessary to complete the research protocol.
• Refine the specific aims, research question hypothesis and/or objectives of the proposed study.
• Coordinate statistical and scientific consultation from CIF staff.
• Develop an individualized timeline for each protocol.
• Complete the necessary documents for approval, including the informed consent, recruitment materials, and data collection forms.
• Coordinate administrative, IRB, and/or IACUC (Institutional Animal Care and Use Committee) approval of proposed research protocols.
• Must Obtain and maintain NIH and CITI training in accordance with local IRB policy.
• Organize and prioritize all activities associated with conducting phase I, II and III clinical trials and clinical studies within a military setting.
• Review and understand biomedical research protocols, ensuring applicable regulations and guidelines are followed.
• Develop source documents for assigned studies, manage data collection, and ensure all Adverse Events (AEs) are identified and reported appropriately.
• Enter required data on paper or electronic case report forms (CRFs), audit records for accuracy, resolve discrepancies, and correct as necessary.
• Collect, organize and maintain all essential documents required for study regulatory files.
• Coordinate with external monitors and internal quality assurance to assure compliance with protocol, Standard Operating Procedures (SOPs), regulations and guidelines.
• Conduct protocol evaluation and feasibility assessment of proposed clinical research.
• Prepare relevant documentation for submission to the Institutional Review Board (IRB).
• Develop patient information and informed consent forms and patient recruitment materials.
• Meet with potential research subjects to explain the research project in detail and enroll eligible subjects into the study by obtaining written informed consent.
• Communicate with the IRB point of contact (POC); as required, in order to maintain protocol renewals and meet any and all interim reporting requirements.
• Provide internal assessment of adherence to approved protocols, as well as all relevant DoD and FDA regulations, under guidance of the Principle Investigator (PI).
• Obtain and maintain NIH and CITI training in accordance with local IRB policy.
• Support the oversight of the CIF’s quality assurance program to ensure compliance with applicable rules and regulations in support of new and ongoing clinical trials and other clinical research activities.
• Develop clinical quality management plans and materials to support the CIF research program.
• Review and assess existing clinical quality assurance efforts.
• Assess adherence to protocols, as well as relevant Air Force, DoD and FDA regulations and guidance.
• Complete routine audits of clinical study documentation and procedures to ensure adherence to above.
• Identify areas of deviation from protocols, ethical standards, regulations and or guidance, and recommend corrective actions.
• Document resolution of findings, analyze data and report non‐compliance to appropriate individuals.

Secondary Activities

• Develop and implement SOPs as or where necessary.
• Prepare research oversight and compliance documents and tools for assessment, as or where necessary.
• Serve as the liaison between study sponsors, investigators, departmental research personnel and other individuals assigned to the study.
• Independently develop training materials and conduct education of physician and nursing staff on specifics of the research protocol, study design, investigational therapeutic agents, procedures and/or techniques specific to the assigned study.
• Perform patient education regarding study participation, outlining protocol and time table of patient requirements.
• Coordinate the activities of research personnel to ensure quality patient care and adherence to research GCP principles.
• Focus on the care of research study patients with regard to each study's safety considerations.
• Work with multidisciplinary teams providing and directing nursing care in a research environment.
• Draw on nursing experience and utilize advanced assessment skills to identify patient care problems, formulate patient care plans and continually revise plans to adjust to changes in complex and unstable patients under routine and emergent conditions.
• Develop and implement SOPs, compliance documentation, and tools for assessment.
• Assist with the administration of procedures related to the development, implementation, management, evaluation, and continuous quality improvement of organizational operations.
• Support and maintain quality corrective action/preventative action system.
• Manage the CIF’s document control system; prepare documents for review and signature, maintain a tracking system for status of SOPs and SSPs, issue SOPs/SSPs both electronically and hard copy, distribute revisions as required.
• Support and maintain clinical study regulatory readiness and actively participate in regulatory inspections. May serve as audit host for regulatory inspections for the 60th MDG CIF program.
• Develop and deliver training in quality assurance/quality control for clinical studies as necessary. Provide for methods to assess competency and maintain supporting documentation.

Qualifications:

Education

• BSN (RN) from accredited Nursing Program
• MS/MA preferred
• Certification in Research Nursing recommended, but not required for hire

Experience

• RN preferred 5 years of experience in clinical, translational, and military research

Knowledge

• Understanding of all aspects of biomedical research protocols, ensuring applicable regulations, and guidelines.
• Understanding of IRB, and/or IACUC (Institutional Animal Care and Use Committee) research protocols and process

Job Type:

On-Site

Travis Air Force Base in Fairfield, CA 94533

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

NUES Inc is an equal opportunity employer. Our policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category.

Applicants must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.