[Hiring] Clinical Research Associate II @Avania

Role Description

Avania’s Clinical Research Associate II (CRA II) establishes, maintains and supports clinical trials. Through the monitoring process, you will verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Further, you will ensure that the conduct of the trial follows approved protocols/amendment(s), with ISO14155 or ICH-GCP, and with applicable regulatory requirements.

Your role will include:

• Clinical Trial Monitoring:
  • Oversee clinical trial activities at investigational sites with a focus on Site initiation visits - SIV (will require travel to investigational sites).
  • Conduct and write accurate visit reports in accordance with SOPs and GCP, including pre-study, site initiation, routine monitoring, and close-out visits.
  • Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols.
  • Ensure data entered on the CRFs by investigational sites is performed in a timely manner and verify that data is consistent with patient clinical notes, known as source data/document verification (SDV).
  • Collaborate with analytical services as appropriate, to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data.
  • Monitor sites' completion of action items between visits.
• Study-Specific Documents and Files:
  • Prepare for audits and inspections.
  • Participate in internal TMF reviews.
  • Review and write informed consent forms.
  • Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development.
• Regulatory Affairs:
  • Prepare submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and assist in administrative tasks for submissions.
  • Prepare confidentiality agreements and complete templates of clinical trial/investigator agreements.
  • Prepare annual trial progress reports for IRBs/ECs and CAs/FDA under supervision.
  • (Assist in) reporting Serious Adverse Event to Sponsor, IRBs/ECs, CAs/FDA and investigators.
• Additional Responsibilities:
  • Participate in project meetings and investigator meetings; write and publish minutes.
  • Perform submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and follow-up until approval is obtained.
  • Prepare clinical trial agreements and discuss/negotiate between site and Sponsor.

Qualifications

• B.A./B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experience.
• Minimum 2+ years of prior CRA experience needed.
• Previous experience with medical device or medical technology studies strongly preferred.
• Ability to understand basic and complex medical details.
• GCP-ICH-E6, FDA regulations and ISO 14155, 13485 and 9001 knowledge where applicable; knowledge of regulatory regulations and guidelines on medical devices.
• Excellent planning and prioritizing skills with a strong client focus and the ability to flex with business needs. Results-oriented.
• Ability to travel up to 75-80% (includes overnight travel - on average, will travel 2-3 days per week, with up to 8 site visits per month).
• Fluent English, good spoken and written communication skills.

Benefits

• The opportunity to work in an innovative, fast-growing and rewarding industry.
• A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties.
• Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities.
• Competitive compensation and benefits package (details shared during the interview process).
• Some roles offer the opportunities for travel.
• Ask us about our hybrid and fully remote work opportunities.

Company Description

Avania takes pride in being an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.