Entdecken Sie eine Karriere mit tieferem Sinn

PURPOSE

Engage in company training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

RESPONSIBILITIES

•     Complete appropriate therapeutic, protocol and clinical research training to perform job duties. 

•     Gain experience in study procedures by working with experienced clinical staff. 

•     Under close supervision, perform site selection (if applicable), initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.

•     If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas to CRA for improving site recruitment plan in line with project needs to enhance predictability. Assist CRA in tracking subject site recruitment progress.

•     Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.

•     Under close supervision, 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. Under close supervision may support start-up phase.

•     Under close supervision, 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.

•     Convey 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

•     Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

•     Good written and verbal communication skills including excellent command of English and Dutch language

•     Good organizational and problem-solving skills

•     Effective time management skills

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

•     Bachelor's degree, preferred in health care or other scientific discipline, or equivalent combination of education, training and experience