Clinical Research Scientist Jobs

Description

The Clinical Research Scientist leads or co-leads the implementation of a clinical trial or clinical trial(s) within program alignment of the clinical development strategy. This role is part of the Medical Affairs team and works in alignment with the Medical Affairs Director and Senior Clinical Development leader as indicated for ongoing clinical-trial-related activities to provide quality and timely deliverables.

This full-time role reports to the Head of Post-Clinical Research Operations.

Essential Functions

• Interact with surgeons, nurses, healthcare providers to understand unmet clinical needs and translate insights into study inputs
• Participate in site selection, feasibility assessment and engagement with KOLs when needed
• Assist in preparing presentations for investigator meetings, CRO/CRA training as warranted
• Assist in the development and review of study plans; serve as a liaison to project teams and CROs
• Assist to execute the clinical trial as indicated in the clinical development plan (CDP)
• Develop and draft clinical trial protocols, informed consent report forms, study reports and other study materials with minimal supervision
• Contribute to the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation and analysis
• Work closely with the Medical Director and Clinical Research leader (as needed)
• Author, present manuscripts, abstracts, poster and other publications
• Perform literature review, support clinical scientific discussions with KOLs and internal and external stakeholders

Requirements

Competencies

• Excellent oral, written, and interpersonal communication skills
• Understanding of product development processes, related healthcare market environments, clinical trends and clinical trial regulation
• Excellent organization, time management, ability to meet deadlines
• Good understanding of clinical research science and processes along
• Ability to work in a project-oriented, team-approach environment

Education & Experience

• PhD, MS or equivalent degree preferably within the medical, biological, regenerative science related discipline
• Prior biomedical device development experience preferred
• 3-5 years of clinical research experience required

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis is an equal opportunity employer.

Salary Description $100k - $105k