kandydatów
Senior Clinical Research Associate (m/f/d)
Firma: Optimapharm d.o.o. miejsce pracy: Kraków
Established in 2006, OPTIMAPHARM is a full-service mid-sized European CRO, that provides tailored solutions and has high-level expertise in managing trials across Europe, with unrivaled access to patients. Our operational excellence and customer-focused approach have led to us achieving a 95% repeat business level.
OPTIMAPHARM's highly experienced team of experts supports a comprehensive network of 24 strategically located offices throughout 22 European countries.
Having offices across Europe, as well as having a network of preferred partners, OPTIMAPHARM is well qualified to manage trials in Europe, Israel and the US, supporting Biotech, Pharmaceutical and Medical Devices companies in reaching large patient populations in various indications whilst achieving competitive start-up timelines at competitive prices.
We are looking for a CRA III or a Senior CRA to join our Clinical Operations team in Poland and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.
Who are we looking for?
- University degree, preferably in medical or life sciences. Individuals with university degree in biotechnical, technical, bio medicinal, social, or humanistic sciences must have nursing education or other relevant healthcare college degree.
- At least 3 - 4 years of independent clinical trial monitoring experience, experience in oncology studies is an advantage
- High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
- Experience in Quality Systems and audit/inspection visits
- Fluent in local language and English; both, written and verbal
- Computer proficiency is mandatory
- Ability to read, analyze, and interpret common scientific and technical journals
- Excellent verbal and written communication skills
- Very good interpersonal and negotiation skills
- Ability to work with minimal supervision, pro-active
- Affinity to work effectively and efficiently in a matrix environment
- Excellent numerical skills and reasoning ability
- A current, valid driver’s license would be advantageous (position requires up to 30% of travel)
- Monitor study sites independently according to the protocol monitoring guidelines, SOPs, GCP ICH guidelines (selection, initiation, monitoring and close-out)
- Manage assigned sites by regular contacts with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
- Support study sites by acting as a liaison between the site and study sponsor and/or clinical vendors
- Prepare accurate and timely trip reports
- Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
- Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution
- Maintenance and management of the relevant project tracking systems as prescribed in the project plans
- Participate in company-required training programs, timely and accurate completion as well as ongoing maintenance of Personal Training Record
By joining our fast-growing and prosperous team, you will have a great opportunity for further personal growth and career development.
If you would be interested in joining the Optimapharm team, please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for the further selection process.
Wyświetleń: 148