COMPANY OVERVIEW, CULTURE, AND ENVIRONMENT
We are launching a globally focused internal CRO to deliver exceptional Clinical Trials results.
We are a high-growth, rapidly evolving, lean organization that prides itself on its fast-paced entrepreneurial style and rewards teamwork, collaboration, and resourcefulness. At our group there is great value placed on accountability and proactive problem-solving to meet timelines and objectives.
The Group CRO is looking to build a team of talented, qualified, and passionate individuals. The organization values diversity, collaboration, and creativity and cultivates a supportive, inclusive workplace, fostering employee growth and development.
POSITION OVERVIEW
The Clinical Research Associate (CRA) will play a vital role in the successful execution of
clinical trials. This role is responsible for ensuring that all site-level activities related to the study
implementation are performed in accordance with the protocol, applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and the company’s standard operating procedures (SOPs).
KEY RESPONSIBILITIES
- Study and Protocol Design and Planning
- Participate in the review of the draft protocol and provide feedback to medical writers and
clinical operations teams
Review CRF and ensure appropriate Medical CodingReview safety parametersParticipate in the development of the Monitoring PlanAssist in developing and reviewing study-related documents, including protocols, informedconsent forms, study manuals, and case report forms.
Serve as the key point of contact for the Principal Investigator (PI) and study site staffResponsible for building and maintaining strong relationships with the PIs, study site staff, andsub-investigators through mutual respect as well as study-specific and general clinical trials
expertise
Become the go-to resource for the PI and site staff regarding questions, problems, and adviceEnsure effective communication and collaboration throughout the trialProvide a bridge between the PI, site staff, and other functional areas of the CRO and the CROleadership team.
Site Feasibility, Site Selection, and Study Start-UpConduct site qualification visits and reportsLead review and negotiation for Study Budget and Clinical Trial Agreements with sitesOversee distribution and collection of essential regulatory documentsParticipate in investigator meetings as neededProactively identify and work with sites and internal operations teams to identify and mitigaterisks in meeting study milestones
Identify site-level resource and training needsWork with the PI and Study Coordinator to proactively ensure patient recruitment andretention plans
o Ensure patient recruitment materials and budget are approved by the appropriate
stakeholders
o Work with sites to ensure an aggressive approach to identifying and prescreening
patients
MonitoringConduct site initiation, routine monitoring, and closeout visits to ensure that the trial isconducted in compliance with the protocol, regulatory requirements, and GCP guidelines.
Identify and resolve study-related issues and deviations from the protocol, escalating asnecessary to ensure timely resolution.
Coordinate with Medical Monitor to review required waivers, identify and manage seriousadverse events (SAEs), and proactively support the PI and site staff to gather required data
and reporting to minimize project impact.
Review and verify clinical data collected during the trial to ensure accuracy, completeness, andcompliance with the protocol and applicable regulations.
Maintain accurate study documentation in accordance with SOPs, including sitedocumentation, site visit reports, monitoring reports, and other study-related documentation.
Contribute to the development and maintenance of the company’s SOPs and quality controlprocedures.
Additional Responsibilities may include :
May review trip reports for more junior CRAsMay conduct internal training for CTAs and CRAsMay be responsible for the preparation and presentation of information during InvestigatorMeetings
May be asked to contribute to Requests for Proposals (RFPs)Perform other duties as assigned by the Clinical Trial ManagerQUALIFICATIONS
Bachelor's degree in a scientific or healthcare-related field, nursing qualification, or relevantexperienceMinimum of 3 years of clinical trial monitoring experience as a CRA based in Germany and proficiency in English, German, and French.Previous experience as a Clinical Research Coordinator, Study Nurse, or Site Director (preferred) Prior experience in the conduct of clinical research, including ICH-GCP requirements, drug / device development process, regulatory compliance, study start-up, or study coordinationWorking knowledge of medical terminology, FDA regulations, and ICH guidelinesExcellent organizational and time management skillsExcellent communication and interpersonal skillsStrong coaching and mentoring skillsAbility to work independently and manage multiple priorities in a fast-paced environmentAbility to think logically and understand complex ideas and dataResilience, determination, flexibility, persistence, and motivationProficient in Microsoft Office (Word, Excel, PowerPoint). Demonstrated ability to learn otherapplications.