* Lead CRA (f/m) - sponsor dedicated, office or home based in Belgium
Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
Member of the core project team and partners with the Project Leader to ensure overall project meets delivery requirements and are conducted in accordance with SOPs, policies and practices.
Senior CRA tasks:
- 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 Project Manager (CPM), Clinical Research Specialist (CRS) 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, generating follow-up letters and other required study documentation.
- Act as a mentor for clinical staff including conducting co-monitoring and training visits.
- May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes.
Lead CRA tasks:
- Represent clinical delivery with customer.
- Ensure appropriate subject recruitment plans are in place; all outreach or digital offerings are explored and deployed in consultation with the customer. Ensure the Site Recruitment Action Plan (SRAP), patient recruitment target and contingency plans are in place and deployed at trigger points.
- Manage clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management and project management forums.
- Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with the Project Leader.
- Collaborate with other functional groups such as Global Delivery Network (GDN), Labs, Data Management, Pharmacovigilence, and Biostatistics, where necessary, to support milestone achievement and to manage study issues and obstacles.
All responsibilities are essential to job functions unless noted as non-essential (N).
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 Harmonization (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 including good command of English language
- Excellent organizational and problem-solving and time management skills
- Ability to manage competing priorities
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
- Proven ability to understand customer needs and appropriately influence decision making
- Effective mentoring and training skills
- Fluent Dutch and French language skills and a good command of English
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in a health care or other scientific discipline or educational equivalent and a minimum of 4 years of on-site monitoring experience; or equivalent combination of education, training and experience
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