Senior Clinical Research Specialist

Department: SENIOR CLINICAL RESEARCH SPECIALIST

DESCRIPTION

The Senior Clinical Research Specialist (CRS) will be responsible for assisting with clinical study management duties and clinical program support to evaluate performance, safety, and efficacy of products. Under direct supervision, the Senior CRS assumes project management responsibilities for selected studies and site management activities as needed. The individual must have the ability to work independently and as an effective and engaged team member in a dynamic, fast-paced environment. As a member of a growing team the Senior CRS must be flexible and willing to carry out tasks outside of their routine responsibilities.

DUTIES & RESPONSIBILITIES

The role of the Senior Clinical Research Specialist includes but is not limited to the following responsibilities and skill sets:

• Performs operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), Good Clinical Practice (GCP) and specific country regulations. Assists as required by the management team in all phases of a clinical trial from startup to closeout: clinical trial plans, protocol development, case report form development, EDC development, user acceptance testing (UAT), site selection, continuous monitoring, study closeout and final report.
• Conduct monitoring visits to ensure compliance with the clinical study as well as local and federal regulations.
• Query management including data reviews and query resolution.
• May support clinical supply operations, site and vendor selection and management.
• Assists with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies
• Assists with site initiation activities, resolution and follow-up of site issues, and study closure activities.
• Provides support and training for clinical study sites to assure data integrity and protocol compliance. Assists in preparation of study materials and/or training and tracks and maintains study documentation. Sets up and maintains accurate clinical study files. Support in the development and updates of study-related documentation, plans and trackers to track project milestones and deliverables
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Submits applicable study documents to the institutional review boards (IRBs) as needed.
• Writes interim and final clinical study reports.
• Assists clinical management with other clinical study duties as requested.

EDUCATION/EXPERIENCE

• Bachelor’s degree and a minimum of 5 years of clinical research experience or advanced degree with 2 years of clinical research experience in the medical device industry.
• At least one year of clinical monitoring experience.
• Basic knowledge of GCP and regulatory compliance guidelines for clinical trials.
• Clinical trial management experience.
• Travel will be required, up to 30%.

MUST HAVE (MINIMUM REQUIREMENTS)

• Bachelor’s degree and a minimum of 5 years of clinical research experience or advanced degree with 2 years of clinical research experience in the medical device industry.
• At least one year of clinical monitoring experience.
• Basic knowledge of GCP and regulatory compliance guidelines for clinical trials.
• Clinical trial management experience.
• Travel will be required, up to 30%.

NICE TO HAVE

• Degree in life sciences or related medical/scientific field.
• Strong knowledge of clinical monitoring functions and clinical research. methodologies, including study design, implementation and reporting.
• Experience with vendor management.
• Experience with Clinical Operations and interfacing with CRO teams.
• CCRA certification (Certified Clinical Research Association) or SOCRA.
• Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web- based applications.
• Project management and organization skills
• Ability to work well in a dynamic, fast paced work environment.
• Ability to shift priorities and work plan based on department needs.
• Excellent written and verbal communication skill.
• Capable of working on multiple projects in a deadline driven environment.

OTHER:

• Don’t meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Neurent we are dedicated to building a diverse, inclusive, and authentic workplace, so if you’re excited about this role but your experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.