Clinical Research Associate (EU)

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 several Clinical Research Associates (CRA) in Europe (Full-time) to join our team. This is an excellent opportunity to contribute to a newly developed in-house CRA team.

Location: 
We are looking for a CRA in The Netherlands, Belgium, Germany (South West area), UK (London area) or France (Paris Area). The CRA can work remotely with periodic visits to the assigned clinical sites within that country. 
 

Key Responsibilities:

Develop strong site relationships across assigned region
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 and one or more of the following languages: French, German or Dutch
Excellent understanding and demonstrated application of ICH-GCP and applicable SOPs
Management of regulatory and / or EC 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.
 

Education and experience:  

Degree in pharmacy, life science or related field
4+ years experience in pharmaceutical, biotech or CRO 
 

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:

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.

You can contact Laura Faber via recruitment@proqr.com if you have any questions.