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 Senior Clinical Research Associates (CRA) in the United States of America (full-time) to join our team. This is an excellent opportunity to contribute to a newly developed in-house CRA team.
Location: United States of America / Remote
• Develop strong site relationships across assigned region, which includes regular on-site visits
• Conduct site feasibility for assigned region and have input into site identification and selection decisions
• Prepare EC submissions and coordinate with study teams on query responses, translation of study-related documents
• Preparation and negotiation of study budgets and collaboration with ProQR Legal on Clinical Trial Agreements
• Ensure trials are conducted in accordance with the approved protocol, ICH-GCP guidelines and SOPs
• Case Report Form (CRF) review, query generation and resolution
• Evaluate opportunities, challenges and trends across regional clinical trial environment and at the site level
• Ensure effective communication between sites and internal/external stakeholders
• Lead/Contribute to initiatives related to process development and improvements
Knowledge, skills, abilities:
• Fluency in English
• Excellent understanding and demonstrated application of ICH-GCP and applicable SOPs
• Management of regulatory and / or IRB questions
• Development and preparation of the local informed consent form
• Experience with risk-based monitoring preferred but not required
• Management of the delivery of study supplies
• Strong customer focus
• Strong interpersonal skills
• Strong attention to detail
• Effective organizational and time management skills
• Proven flexibility and adaptability
• Ability to work in a team or independently as required
• A nice person :-)
Qualifications that are required for making the difference:
• Degree in pharmacy, life science or related field
• 4+ years experience in pharmaceutical, biotech or CRO
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
• 8% holiday allowance
• 30 vacation days
• An annual performance bonus
• Stock options
• A premium-free pension plan
• A commuting allowance
• A subsidized staff restaurant
• Flexible working arrangements
• Unlimited (un)healthy snacks and drinks
• Employee events (boot camp, chair massage and other social events)
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.
You can contact Yessica De Brouwer via firstname.lastname@example.org if you have any questions.
Please note that a screening is part of our selection procedure.