Clinical Research Associate (USA)
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 Clinical Research Associate (CRA) in the US (Full-time) to join our team. This is an excellent opportunity to contribute to a newly developed in-house CRA team.
Cambridge, USA or remotely
- Develop strong site relationships across assigned region (USA & Canada)
- Conduct site feasibility for assigned region and have input into site identification and selection decisions
- Prepare IRB/REB 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 and abilities
- Excellent understanding and demonstrated application of ICH-GCP and applicable SOPs
- Management of regulatory and / or IRB/REB 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 CR.
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 Unlimited vacation days
- 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 are looking forward to receiving your application by filling out our application form.
You can contact Femke Hekelaar via firstname.lastname@example.org if you have any questions.