ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
Our Clinical Operations department is currently looking for a highly motivated Clinical Trial Coordinator (full-time) to strengthen our team.
Location: United States of America / Remote
We expect our Clinical Trial Coordinator to:
• Assist Clinical Operation functions with day-to-day logistics of assigned clinical studies (study start-up, study execution and close out) including project planning and internal & external communications
• May participate in operational feasibility of the protocols; assist with the assessment, selection and management of vendors; think along in strategies ensuring timely subject enrolment against plan
• Assist with, or if outsourced assist in overseeing, clinical trial startup activities
• Assist in the development of study related documents and plans and help with distribution and filing
• Support the Clinical Trial Manager in study team activities such as trial documentation management, milestone tracking and identification, resolution and escalation of issues (as appropriate)
We want our Clinical Trial Coordinator to have hands-on experience with the following essential responsibilities:
• Participate in, or if outsourced assist in overseeing, the maintenance and accurate updates of trial level data in CTMS, TMF or other relevant business systems
• Assist with writing routine and ad hoc project updates, as needed
• Assist with the preparation for and conduct of internal team meetings, investigator meetings and other trial-specific (cross functional) meetings
• Support in overseeing and tracking site payments and vendor invoices
• Coordinate meetings, information and timelines to contribute to the monitoring of the deadlines
• Support the maintenance of clinical trial registrations on databases such as clinicaltrials.gov.
• Provide general administrative support to the clinical team
• Work closely with the internal and contract research organization teams to ensure completion of the allocated tasks
• Represent the company with a high level of integrity and professionalism
• Adhere to company’s policies and support team decisions and goals in a positive, professional manner
• May take over responsibilities of Clinical Trial Manager, if required and in case of his/her absence
• Perform other duties as assigned
Skills that are required for making the difference:
• An understanding of clinical research and the drug development process
• Knowledge of Good Clinical Practice, ICH guidelines and regulatory requirements
• Good analytical and interpersonal skills are mandatory
• Excellent planning, organizational, leading and managing multiple priorities, and time management skills
• Extensive computer skills, including the use of Microsoft Office. Requires strong Word processing, spreadsheets, database and other applicable software programs/system operation skills
• Flexible, proactive and solution focused
• Strong verbal and written communication skills
• Fluency in English
• High level of initiative and ability to work independently; self-motivated, detailed oriented and achievement driven
Qualifications that are required for making the difference:
• Minimum Bachelor’s degree in a scientific discipline and/or at least two (2) years’ experience in clinical trials or related experience in the pharmaceutical industry or in a clinical setting
• Ophthalmology experience will be an advantage
ProQR as an employer
As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things.
We are committed to ensure that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
- A competitive salary
- An annual performance bonus
- Stock options
- A medical, vision and dental plan
- A 401k pension plan
- A commuting allowance
- Flexible working arrangements
- Unlimited (un)healthy snacks and drinks
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible if you are interested in this position.
Please note that a screening is part of our selection procedure.