Job expirat
Our client, a major pharma company with the entrepreneurial spirit and agility of a successful biotech company is looking for professionals to fill in the position of Clinical Site Monitor.In this role you will be primarily responsible for performing clinical research duties that include leadership in the following areas: site selection and initiation, clinical study monitoring and management, cooperation with CROs/vendors as well as related duties.
Main tasks:
Identifies, evaluates, and recommends new potential investigators/sites on an on-going basis through medical community networking to assist in the placement of planned clinical studies with qualified investigators;
Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits. Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements;
Reviews site activities through frequent visits and contacts to monitor study sites to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations (Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory; Ensures safety and protection of study subjects; Ensures documented follow-up to all outstanding issues; Facilitates the Regulatory Compliance audit process, as needed);
Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, tactful and objective manner;
Interacts and builds professional and collaborative relationships with all study personnel;
Employs good fiscal management to conserve the costs of departmental operation and controls travel expenses;
Bachelors degree (or equivalent) in Biology or health related field;
4-6 years of clinically related experience, of which at least 2-3 years must be clinical research monitoring;
Advanced and thorough knowledge related to ICH GCP Guidelines, and/or FDA GCP regulations, and applicable local regulations;
In-depth knowledge and understanding of appropriate therapeutic indications;
Excellence in the on-site monitoring of investigational trials, as confirmed by line manager assessments and Regulatory Compliance audit results, if applicable;
Knowledge of recent advances in medicine and medical technology;
Demonstrated strong site management and monitoring skills;
Attention to detail, acute observational skills, analytical and conceptual capabilities;
Has demonstrated competence in the use of personal computers as a tool for the performance of previous positions/activities, including a mastery of word processing, spreadsheets, e-mail and web-browser applications;
Effective, proactive communication to impact and influence office based staff and clinical research site personnel;
Strong ability to work independently, with minimal direct supervision.
Company offers opportunities to meet with people of various nationalities and establish an international network.
Other notes
In case of your interest to apply for this position, please, send us your curriculum vitae both in Romanian and English language with the ref. number in subject of your application.
If you've had an interview in Grafton already, please, contact your consultant directly via e-mail.
Numărul de referinţă 1-14-1319
Founded in 1982, Grafton Recruitment has established itself as a world class provider of recruitment solutions. Grafton has experienced an impressive growth pattern in the last five years. The network has built to a total of 70 branch operations spanning 19 different countries including the United Kingdom, Republic of Ireland, Chile, Czech Republic, Slovakia, Hungary, Poland, Lithuania, Russia, Portugal, France, Austria, Belgium, Turkey, UAE and Romania.