We are looking to recruit committed individuals to work in a busy clinical research department providing essential monitoring support.  

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

RESPONSIBILITIES

• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice

• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

• 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 as appropriate. 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. May support start-up phase

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation

• Build awareness of features and opportunities of study to site

• Collaborate and liaise with study team members for project execution support as appropriate

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

• Good 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 lap top computer

• Good written and verbal communication skills including good command of English language and Bulgarian.

• Good organizational and problem-solving skills

• Effective time management skills

• Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor's degree in a health care or other scientific discipline or educational equivalent and successful completion of a CRA Trainee Program

• At least 6+ months of on-site monitoring experience in a CRO or pharmaceutical environment

• Fluent in English and Bulgarian

• Availability to travel 80%

The role provides the opportunity to develop monitoring skills with advanced responsibilities, critical and central to the conduct of the clinical project. We are offering a hybrid flexible working place model (home-office) based.

Unleash your Potential!

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com