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nasdaq:cdtx
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www.cidara.com
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www.cidara.com
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Aug 9th, 2018 12:00AM
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Senior Clinical Research Associate
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Open
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Clinical
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San Diego, CA, United States
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San Diego
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CA
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USA
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Aug 6th, 2018 12:00AM
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Position SummaryThe Sr. CRA provides trial oversight of investigational sites, CROs and vendors. This role also assures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans. The Sr. CRA will also be responsible for monitoring all phases of clinical trials, as needed. This position will also provide input, support and maintenance of department clinical projects and infrastructure. The Sr. CRA reports to the Director of Clinical Operations.ResponsibilitiesVendor (e.g., CRO, Biometrics, IWRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines and organizational objectives and goals.Contributes to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes for assigned studies within the department.Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.Gains an in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.Participates & provides input on study site selection activities.Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.Performs remote and on-site monitoring & oversight activities using various tools to ensure:Data generated at sites is complete, accurate and unbiasedSubjects’ right, safety and well-being are protectedMay conduct site visits, including but not limited to, site selection, site initiation, interim monitoring, close-out, CRA oversight, and co-monitoring. Records in support of these monitoring visits must be timely, clear, comprehensive and accurate.Performs timely review of monitoring reports and associated deliverables demonstrating sponsor oversight.Collects, reviews, and monitors required regulatory/operational documentation for study start-up, study maintenance and study close-out.Supports clinical document control activities and associated study staff to ensure the content and management of the electronic/paper Trial Master File (eTMF/TMF) is current and inspection-ready.Perform periodic reviews of the eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined process as appropriate in collaboration with clinical operations management.Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.Supports audit/inspection activities as needed.Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements.Minimum Qualifications BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered.5 years of direct site management (monitoring) experience in a Biopharmaceutical or Pharmaceutical company, with Phase 1 through 4 trials, both domestic and international.5 years study oversight experience (e.g., CRO/vendor oversight).Travel up to 40% with overnight stays.Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.Excellent understanding and working knowledge of clinical research, phases of clinical trials, current ICH GCP & country clinical research law & guidelines.Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.Demonstrated ability to mentor/lead.Hands on knowledge of Good Documentation Practices.Performs independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites and therapeutic areas.Strong IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.Ability to understand and analyze data/metrics and act appropriately.Possesses effective time management, organizational and interpersonal skills, conflict management, problem-solving skills.High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.Works effectively in a matrix cross functional environment. Ability to establish and maintain culturally sensitive working relationships.Works with high quality and compliance mindset. Preferred Qualifications Preferred experience in monitoring/managing Infectious Disease and/or Oncology clinical studiesThe content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company
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Aug 9th, 2018 12:53AM
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Aug 9th, 2018 12:53AM
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Cidara Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cdtx
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www.cidara.com
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www.cidara.com
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Jun 19th, 2018 12:00AM
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Junior System Administrator
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Open
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Information Technology
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San Diego, CA, United States
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San Diego
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CA
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USA
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May 29th, 2018 12:00AM
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Jun 18th, 2018 11:25PM
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Jun 18th, 2018 11:25PM
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Cidara Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cdtx
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www.cidara.com
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www.cidara.com
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Jun 20th, 2018 12:00AM
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Junior System Administrator
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Open
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Information Technology
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San Diego, CA, United States
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San Diego
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CA
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USA
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May 29th, 2018 12:00AM
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Jun 19th, 2018 11:29PM
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Jun 19th, 2018 11:29PM
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Cidara Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cdtx
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www.cidara.com
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www.cidara.com
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Jun 23rd, 2018 12:00AM
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Junior System Administrator
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Open
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Information Technology
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San Diego, CA, United States
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San Diego
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CA
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USA
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May 29th, 2018 12:00AM
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Jun 22nd, 2018 11:37PM
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Jun 22nd, 2018 11:37PM
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Cidara Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cdtx
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www.cidara.com
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www.cidara.com
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May 30th, 2018 12:00AM
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Associate Director, Clinical Supplies
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Open
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Clinical
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San Diego, CA, United States
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San Diego
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CA
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USA
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May 23rd, 2018 12:00AM
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May 30th, 2018 03:55AM
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May 30th, 2018 03:55AM
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Cidara Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cdtx
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www.cidara.com
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www.cidara.com
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May 31st, 2018 12:00AM
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Junior System Administrator
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Open
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Information Technology
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San Diego, CA, United States
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San Diego
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CA
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USA
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May 29th, 2018 12:00AM
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May 31st, 2018 12:13AM
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May 31st, 2018 12:13AM
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Cidara Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cdtx
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www.cidara.com
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www.cidara.com
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Jun 1st, 2018 12:00AM
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Junior System Administrator
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Open
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Information Technology
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San Diego, CA, United States
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San Diego
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CA
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USA
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May 29th, 2018 12:00AM
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Jun 1st, 2018 12:47AM
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Jun 1st, 2018 12:47AM
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Cidara Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cdtx
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www.cidara.com
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www.cidara.com
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Jun 3rd, 2018 12:00AM
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Associate Director, Clinical Supplies
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Open
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Clinical
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San Diego, CA, United States
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San Diego
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CA
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USA
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May 23rd, 2018 12:00AM
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Jun 3rd, 2018 01:39AM
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Jun 3rd, 2018 01:39AM
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Cidara Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cdtx
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www.cidara.com
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www.cidara.com
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Jun 4th, 2018 12:00AM
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Junior System Administrator
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Open
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Information Technology
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San Diego, CA, United States
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San Diego
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CA
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USA
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May 29th, 2018 12:00AM
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Jun 4th, 2018 12:45PM
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Jun 4th, 2018 12:45PM
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Cidara Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cdtx
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www.cidara.com
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www.cidara.com
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Jun 8th, 2018 12:00AM
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Research Associate, In Vivo
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Open
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Preclinical Development
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San Diego, CA, United States
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San Diego
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CA
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USA
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Jun 5th, 2018 12:00AM
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Jun 8th, 2018 02:51AM
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Jun 8th, 2018 02:51AM
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Cidara Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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