Sr CRA | Taiwan
Syneos Health Clinical台灣Update time: September 17,2019
Job Description
Sr CRA | Taiwan
- (18008262)
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
- The Senior Site Clinical Research Associate (Sr. SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites. May be responsible for assignments of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues).
- Additionally, the Sr. SCRA may train and provide guidance to junior staff.
- Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs) and business processes.
- Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
- Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues, than those assigned to SCRAs.
- Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives. Is proactive in managing the site and ensures action plans are put in place as needed to ensure compliance.
- Reports monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.
- Participates in field training and mentoring of new/junior SCRAs as well as insourced SCRAs. May provide input relative to performance review and development opportunities.
- Proactively identifies issues that may impact enrollment and recruitment timelines, and provide objective comments regarding these issues. Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met.
- Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.
- May coordinate local SCRA team working on the same projects, when applicable.
- Supports remote monitoring, if and as applicable.
Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Minimum Education and Experience Required
- Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing)preferred.
- Minimum of 3 years of clinical related experience, with a minimum of 2 years as
- clinical research monitor.
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Excellent knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Experience in on-site monitoring of investigational drug in multi-therapeutic areas desired.
- Proven strong site management and monitoring skills
- Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Excellent written and verbal communication skills. Written and verbal fluency in
- English and local language (if not English).
- Acute observational skills, analytical and conceptual capabilities.
- Exhibits high degree of flexibility when facing changes in the work environment. Attention to detail and strong interpersonal skills.
- Proficiency in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications.
- Working knowledge and experience with electronic data capture systems and clinical trials management systems.
- Strong ability to work independently in a geographic region with minimal supervision.
Job Clinical Monitoring
Schedule Full-time
Travel No
Employee Status Regular
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