Clinical Research Associate/Clinical Field Specialist - US based

Precirix is a clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing novel radiopharmaceuticals, using camelid single-domain antibody fragments labelled with radioisotopes. The company’s lead product, CAM-H2, is being evaluated in a Phase I/II trial targeting metastatic HER2-positive cancer. In addition, the company has several pre-clinical programs leveraging the technology strengths.

For the expansion of our US Clinical Operations team, we are currently looking for an enthusiastic and experienced Clinical Research Associate/Clinical Field Specialist.

Purpose of the Position:

The Clinical Research Associate (CRA)/Clinical Field Specialist is part of the clinical study team and supports the Clinical Study Expert with the execution and/or oversight of the clinical study by ensuring quality and compliance to SOPS, ICH-GCP and other applicable legislations from study start-up throughout the entire study duration. The CRA is ultimately responsible for the set-up, coordination and supervision of the study on a site/country level.

Key Responsibilities

  • IEC/IRB and CA: perform and/or oversee submissions.
  • Feasibility: identify potential sites for participation in the study, perform site selection visits and/or support and oversee clinical vendor during feasibility phase (co-create selection slide deck, attend selection visits, review site selection reports).
  • Study initiation & activation: perform initiation visits and/or oversee initiation visit process performed by clinical vendor: co-create SIV training slide deck, review SIV reports, verify if all training is in place prior to site activation, review regulatory green light packages.
  • Interim site management: be the key contact on site level and/or be the key contact for the clinical vendor CRA. Review IMV reports. Support in issue solving. Makes sure safety, wellbeing and human rights are protected and enforced at all times. Support protection of data integrity.
  • Data management: assist in data cleaning/query resolution process. Closely follow-up with vendor to ensure timely DB lock.
  • Study closure: perform close-out visits and/or oversee close-out process of clinical vendor. Ensure timely closure of the study.
  • Oversight: assist the Clinical Study Expert in creating and complying to the study-specific oversight Plan. Assist the Clinical Study Expert in identifying risks and evaluate them on a regular basis (Risk Management).

Skills, Expertise and Competences

Qualifications & Expertise

  • Expected educational qualifications: medical or paramedical MSc or equivalent by experience.
  • Wide-ranged experience in clinical research (min. 6 years) and a thorough understanding of GCP and ICH principles.
  • Background in oncology trials is a plus.

Skills & Competences

  • Ability to adhere to high ethical standards, GCP and legal and regulatory requirements.
  • Excellent communication skills (verbal, written and interpersonal) and negotiation skills.
  • Demonstrates strong analytical, problem-solving skills, eye for detail.
  • Ability to understand technical, scientific and medical information.
  • Ability to work highly independent across multiple studies, projects and sites.
  • Must be a result orientated multi-tasker, quick learner and able to work in a fast-changing environment.
  • Excellent oral and written communication skills in English.
  • High quality and compliance mindset.
  • Fluent in English, any other language is an asset.
  • Excellent computer skills.
  • Willingness to travel.

Our offer

  • An environment with nice colleagues that value a cooperative environment.
  • Homeworking.
  • Scale up company with a lot of opportunities and entrepreneurial atmosphere.
  • Company with the mission to improve the life quality of patients.
  • Team with different nationalities working together towards the same goal.

Want to explore this opportunity? Mail us at jobs@precirix.com with a letter of motivation and your cv; and we will get in touch with you.

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