Clinical Affairs Associate

We are seeking a highly motivated and detail-oriented Clinical Affairs Associate to join our dynamic team. The successful candidate will play a crucial role in supporting Clinical Affairs activities, ensuring compliance with regulatory requirements, and contributing to the overall success of our clinical studies. You will have an opportunity to play a significant part in making the latest diagnostic tests and devices available quickly and safely to clinicians and their patients.

• Assist in the planning, coordination, and execution of clinical studies.
• Assist in drafting clinical study protocols and procedures, including informed consent forms, monitoring plans, and data collection forms in collaboration with study project teams.

• Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases.
• Conduct in-house and site (if applicable) reviews of associated documents to ensure all essential clinical Trial Master File documents are compliant with Good Documentation Practices, Healgen internal SOPs, and US regulations.

• Assist in reviewing clinical protocols and Institutional Review Board (IRB) submissions.
• Manage trial master files, budgets, and agreements for assigned studies.
• Assist with the development of study databases for managing clinical data.

• Partner with cross-functional team (e.g., clinical data management) with query management, data reviews and resolution.

• Maintain accurate and up-to-date clinical trial documentation and assist in analyzing and reviewing clinical data and reports.
• Prepare reports for study initiation, monitoring, and close-out visits.

• Sample acquisition and sample banking for analytical and clinical studies.
• Perform tasks for your level and provide coaching and instructions for the levels below.

• A bachelor’s degree in health care or other scientific discipline is required.
• 0-3 years of relevant experience in Clinical Affairs, clinical research, or a related field (experience with in vitro diagnostic devices preferred).

• Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Basic working knowledge of IRB guidelines and Common Rule.
• Demonstrated experience applying clinical research regulatory requirements, such as Good Clinical Practice, International Conference on Harmonization, and HIPAA guidelines.
• Possesses strong written and verbal communication and presentation skills.
• Strong research, analytical, critical thinking, and problem-solving skills.
• Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
• PC/Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience is a plus).
• Basic understanding of U.S. Food and Drug Administration laws and guidance on clinical studies.
• Knowledge in basic statistical analysis.
• Effective interpersonal skills.

Please note this position is office.