PL – 6200
Assistant Site Clinical Research Associate
Part-time (0.4 FTE), permanent
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
- Supports the (Associate)/(Senior) Clinical Operations Manager, Site Clinical Research Associates and any other clinical research personnel involved, in the in-house organization, management and execution of projects to ensure the clinical trials are conducted, recorded and reported in accordance with the protocol, Standard Operation Procedures and applicable global, local and regulatory requirements and company objectives.
- The Assistant Clinical Research Associate is key participant in the study startup activities and site opening activities as well as study conduct and site closure tasks.
- May manage the activities of clinical Investigative sites as they relate to clinical studies to ensure successful execution of the protocol. This position may assume independent site management responsibility in accordance with experience and performance.
- Supports and/or conducts (accompanied) site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs) and business processes, if applicable.
- Conducts assigned clinical site activities and/or supports the (Sr.) SCRA in those according to the monitoring plan and in accordance with the study timelines and company objectives.
- Supports SCRAs with Clinical Trial Application submissions, including relevant informed consent local changes and translations into local language as required.
- Supports remote monitoring, if and as applicable.
- Assists to conserve costs of departmental operation and control of travel expenses, with guidance from (Sr) Clinical Operations Manager.
Minimum Education and Experience Required
- Appropriate life-science or healthcare-related qualification or experience or equivalent work experience.
- Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
- One year of clinically-related experience in a medical profession, pharmaceutical, or diagnostic company is preferred.
- Good planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Good written and verbal communication skills. Written and verbal fluency in English and Ukrainian.
- Good observational skills, analytical and conceptual capabilities.
- Attention to detail and strong interpersonal skills.
There are many benefits available to employees of INC/inVentiv. They include highly competitive compensation and benefits including: 24 days annual leave, car allowance, health insurance, additional vacation, life and accidental insurance and lunch allowance.