Clinical Research Associate
The world's leading pharmaceutical services organization is powering the next generation of healthcare. If you want to make a difference in global healthcare, Quintiles is the place for you. You'll be connected with an organization that is changing the way drugs are developed, profiled and marketed. More than 27,000 people throughout the world have already chosen to join Quintiles.
Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one. This is an outstanding opportunity to join Quintiles as a Clinical Research Associate and become an integral part of our clinical study team.
We are looking to recruit a committed individual to work in our Large Scale Functional Resourcing department in Sofia, Bulgaria providing essential monitoring support to one of our main clients. The role provides the opportunity to develop monitoring skills with advanced responsibilities, critical and central to the conduct of the clinical project. The CRA oversees the progress of a Clinical Trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good
- clinical practice.
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to
- manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to
- applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment,
- case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by
- submitting regular visit reports and other required study documentation.
- Act as a mentor for clinical staff including conducting co-monitoring and training visits.
We are seeking enthusiastic and motivated individuals who want to stretch themselves in an environment that encourages learning. Able to work independently, you will enjoy communicating with others as you will meet a variety of healthcare professionals at monitoring sites, and interact with teams at Quintiles.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a health care or other scientific discipline or educational equivalent and min. 1 year on-site monitoring experience; or equivalent combination of education, training and experience
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- In depth therapeutic and protocol knowledge as provided in company training
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
- Strong written and verbal communication skills in the Bulgarian language including good command of English language
- Excellent organizational and problem-solving skills
- Effective time management skills
- Ability to manage competing priorities
- Effective mentoring and training skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients