Sr. Clinical Research Associate (Sr. CRA)
The Sr. Clinical Research Associate will assist with operational oversight of NKMax America’s clinical programs, including the planning, conduct, and completion of assigned clinical trials. In collaboration with the Clinical Operations team, the Sr. CRA will support CRO and site management, ensuring timely, quality conduct of NKMax America’s clinical trials in accordance with protocols, Good Clinical Practice, and all applicable regulations. The Sr. CRA will also have responsibilities for management and monitoring of specific investigative sites to ensure subject safety and compliance with the study protocol, timeline and budget, in support of on time and within budget regulatory submissions.
- Plan, guide, and report on the conduct of clinical research studies within compliance of state and federal regulations, industry standards and corporate policies.
- Effectively manage multiple clinical studies/sites to assure accurate and timely initiation, enrollment and conduct while providing moderate level study management support.
- Under the support of a Clinical Trial Manager, contribute to study development, conduct and closure.
- Lead project teams, providing input to study design, risk analysis and clinical consultation relative to therapeutic area.
- Create, review and/or revise study documents, including but not limited to site informed consent documents, monitoring plans, and annotated monitoring visit reports.
- Assist with identifying investigators/sites.
- Assist in testing and training study team on clinical trial systems (e.g., electronic data capture systems or electronic trial master file systems).
- Develop and implement training plans for personnel, including CRAs, CRA Assistants, and site personnel.
- Provide leadership and monitoring support to CRO or field monitors
- Responsible for study start-up activities including managing trial documents.
- Review and approve completed monitoring visit reports.
- Review study results with the study team and contribute to final reports.
- Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) approvals.
- Train site personnel to ensure compliance with study requirements.
- Evaluate study enrollment and work with assigned sites to meet enrollment targets.
- Assess eCRFs for trends in safety, efficiency, and adherence to protocol.
- Perform on-site monitoring activities when needed.
- Ensure all documentation is filed within the Trial Master File.
- accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.
- Prepare, submit and file high quality monitoring visit reports and follow-up letters for assigned sites in a timely manner.
- Lead and attend study team meetings and share pertinent information with study team members.
- Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
- Ensue all equipment/supplies provided to investigative sites is appropriately reported.
- Maintain effective working relationships with affiliate teams and external vendors
*The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- Bachelor’s Degree or equivalent experience required along with a minimum of 3 years of independent on-site monitoring experience with all types of site visits
- Strong understanding of ICH/GCP guidelines, including a strong understanding of regulatory requirements and the clinical trial process.
- Knowledge of medical terminology, clinical research acronyms, and medical/scientific abbreviations.
- Able to travel via airplane, train, or motor vehicle to respective research sites or investigator meetings.
- Must be able to travel out of the local office or from home up to 75% of the time, including overnight stays at hotels or other designated facilities.
- Must be able to drive and have a valid driver's license.
- Understand and apply knowledge regarding local, state, and country regulations and industry guidelines, e.g., HIPAA, CA Bill of Rights, International Conference on Harmonization (ICH), and Good Clinical Practices (GCP's).
- Solid knowledge of electronic systems e.g. e-CRF, electronic Trial File Master (e-TMF), and Clinical Trial Management System (CTMS).
Benefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!