Department: Clinical Operations
Reporting: Director of Clinical Operations
The Senior Clinical Research Specialist (CRS) will be responsible for assisting with 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:
- Oversees, plans and conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
- 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 and may prepare clinical trial budgets.
- May support clinical supply operations, site and vendor selection and management.
- Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
- Assists with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
- Assists as required by the management team in overall clinical management plan, protocol and case report form development.
- 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.
- Verify source data/documents and other trial records are accurate, complete, and maintained.
- Query management including data reviews and query resolution.
- Assists clinical management with other duties as requested.
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements listed below must be evident on your resume.
- Bachelor’s degree and a minimum of 5 years of clinical research experience or advanced degree with 2 years of experience (i.e., clinical monitoring, clinical site coordinator, sponsor research coordinator)
Nice to Have (Preferred Qualifications):
- Degree in life sciences, or related medical/scientific field.
- Clinical Research experience in the medical device industry.
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
- CCRA certification (Certified Clinical Research Association) or SOCRA.
- Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation and reporting.
- Experience with Clinical Operations and interfacing with CRO teams.
- Experience with vendor management.
- 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 – demonstrated skill under pressure.
- Travel will be required.
To apply for this position, please send an email with your resume attached to [email protected]