Job Description

Position Purpose :

The primary purpose for this role is to support day-to-day pre-market clinical trial operations, primarily in-house but with occasional support on-site. The role will immediately be responsible for supporting the planning, conducting, and execution of clinical trials within the US. This role is based in Cambridge, Massachusetts, USA.

Scope of Duties and Responsibilities:

• Preparing/managing study documents, coordinating shipping/tracking of investigational product, supporting data collection and management, and reporting/tracking clinical trial progress.
• Work to ensure trials adhere to study protocols, applicable SOPs, regulatory regulations, ICH/GCP guidelines, and government regulations.
• Provide guidance, leadership, and management of clinical sites to ensure audit readiness and protocol compliance.
• Participates as needed in the management of relations with professional and governmental organizations globally including regulatory audit activities and providing information to support regulatory submissions.
• Ensures studies and clinical/data deliverables are performed with quality standards and in accordance with Good Clinical Practice (GCP), International Conference of Harmonization (ICH) guidelines, federal regulations, and Standard Operating Procedures (SOPs) and other regulatory requirements including but not limited to HIPAA, ISO guidelines, etc.
• Assists with evaluating clinical site and vendor performance, including potential occasional field co-monitoring/auditing.
• Developing and maintaining strong knowledge of all technical aspects of Neural Ice and occasionally supporting Neural Ice investigational study cases.

Education / Experience:

• Bachelor's degree, preferably in life sciences or similar field (nursing, pharmacy, etc.) and/or extensive work experience in clinical research.
• 3-5 years of clinical research experience with at least 2 years of device/pharma company experience.
• CRA certification and/or experience in the orthopedic/pain/musculoskeletal medicine space (especially startup) highly desirable.

Skills / Qualifications:

• Experience working in a fast-paced innovation focused organization.
• Experience with physician engagement and clinical site management.
• Experience working in health care facility environments.
• Strong experience with pre-market medical device (feasibility and pivotal) and/or equivalent regulated drug device clinical studies.
• A solid knowledge of Good Clinical Practice.
• Exceptional business communication skills (e.g. – verbal, written, presentation); both external and internal.
• Experience engaging with cross-functional teams required.
• Critical Thinking and Problem-Solving: Ability to analyze complex medical and scientific information, identify potential issues or risks, and develop practical solutions.
• Ethical Standards: Commitment to maintaining ethical standards in clinical research, including patient privacy, informed consent, and protection of human subjects.
• Ability to travel and use remote/digital tools to perform training and occasional monitoring functions.

Salary commensurate with skills and experience.

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