Senior Clinical Research Associate - West Coast Region United States,
The primary responsibilities of this position is to conduct routine site monitoring visits and participate in site selection, site initiation and study closure activities. This person will ensure that the clinical trial is being conducted according to the approved protocol, amendments and in compliance with Good Clinical Practice (GCP), Company SOPs, and all applicable regulatory requirements. The geography for this Senior Clinical Research Associate position will be within the West Coast region. Optimal candidate locations would be in the California - Los Angeles/San Francisco areas. Relocation is not available. Travel is required and will likely be 80%.
- Responsible for evaluation, initiation, monitoring, close-out and other tasks associated with the management of clinical sites. Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP)
- Serve as primary contact for CROs/vendors, Investigators and study coordinators for study related questions.
- In conjunction with study team, support feasibility and site selection process for clinical studies.
- Assist and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Case Report Forms, Source Documents, Monitoring Plan, Data Management Plan, Project Management Plan, etc.)
- Manage patient recruitment strategies to increase patient randomization into the trial (eg investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
- Review all AE/SAEs and ensure appropriate documentation is in place and any other safety issues are addressed and communicated.
- Assist and support data validation and data cleaning procedures to ensure timelines are met.
- Order and coordinate study supplies for clinical studies
- Develop and maintain tracking tools to support management of clinical studies
- Plan and participate in Investigator meetings and CRA trainings
- May accompany CRO/CRA?s to co-monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCP?s), SOP?s and study protocols
- The role will also provide guidance, clinical trial management and direction to other junior Clinical Research Associates.
- Position requires BA/BS or RN, preferably in the Life Sciences
- Minimum of 5+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock.
- Strong Oncology monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials
- Possess good understanding of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
- Good knowledge of concepts of clinical research and drug development
- Strong working knowledge of EDC, IVR and CTMS systems
- Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information
- Demonstrated strengths in planning, organizational, project management, analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
- Ability to travel 70-80%
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