Clinical Trial Coordinator

The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development.

Together we are creating the exciting future of BioInvent, and we welcome you to be part of it as

Key Responsibilities

The Clinical Trial Coordinator will be part of our clinical development team and contribute in assuring a comprehensive clinical study management and operation for the day-to-day work.

Main Responsibilities

• Review or prepare study documents such as study specific plans, manuals, eCRF/guidelines, ICF, trial protocol.
• Participate in vendor selection and management.
• Plan, manage and track study different trial oversight activities.
• Contribute to risk management activities.
• Oversee monitoring activities performed by CRO, review monitoring reports, participate in monitoring visits.
• Oversight and coordination of kit supply and sample shipment to central labs.
• Oversight of study records and documentation (TMF).
• Support IMP handling and tracking.
• Contribute to implementation and maintenance of clinical Quality Management System and ensure compliance with applicable SOPs and relevant national and international regulations and guidelines.
• Provide support to in change controls, GCP and protocol deviations, CAPAs.
• Support clinical trial applications to regulatory authorities and ethics committees as needed.
• Participate in external meetings and internal clinical /cross-functional meetings.
• Work closely with cross functional teams at BioInvent (e.g., with manufacturing, pre-clinical/translational, regulatory affairs, clinical pharmacology, quality).

Qualifications

• University degree (BSc, Masters or PhD) in natural sciences/engineering or degree in nursing.
• Five (5) years of clinical research experience as a clinical study coordinator or clinical research associate from CRO, Pharma and/or Biotech companies.
• In-depth knowledge of ICH-GCP and ensure to attend and receive ongoing training to relevant regulations and guidelines.
• Excellent verbal and written communication skills in English.
• Excellent experience in Microsoft Office suite of applications.
• Ability to work with multiple projects and tasks simultaneously.
  
  

We are looking for a driven, structured, self-motivated, independent, and responsible person, who understands complex projects and interdependencies and easily collaborates and communicates with others both verbally and in writing. You have excellent problem solving and negotiation skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.

Personal suitability is of great importance, we nurture a culture of teamwork, positive team spirit and promote the development of each member in the team. We believe that you are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines, and securing high quality within your work. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.

The position is office-based in Lund. However, the position may also offer a flexible working arrangement.

Starting Date: as soon as possible

Application

BioInvent has several value driving factors in place with great potential for the future. If you match the described profile and would like to contribute to important cancer research, you are welcome to apply for the position!

Please send us your application, personal letter and CV and tell us why you are the right person for this position, at the latest 28th of April 2024. Interviews will be held continuously which means the positions can be filled before deadline.

BioInvent has a collective agreement and contact persons for the Unions are:

Matilda Rehn, Akademikerföreningen and Jenny Nilsson, Unionenklubben.

Vår framtid som dynamisk organisation är till stor del beroende av våra medarbetares kunskap, kreativitet och kompetens. Som en relativt liten organisation har vi en informell och flexibel arbetsmiljö som ger många möjligheter till professionell och personlig utveckling.