Do you thrive in a fast paced environment? Do you have the passion and drive to manage multiple clinical study sites? Do you have experience with international (EU) regulations and study management? Can you connect the dots with your critical thinking skills?
If your answer is yes, then we may be looking for you!
Spectranetics, recently named one of the “Most Trusted Companies”, has an opening for a Senior Clinical Research Associate.
What You Will Do: You will work with our European Clinical Project Manager and international team to satisfy applicable regulatory standards and company requirements for worldwide Clinical Studies. You will also bridge the responsibilities of our CRA-I and Clinical Field Specialist, and focuses on study management activities, provide oversight of CRO and other important activities.
What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with a great team of dedicated experts and leaders in the Medical Device Industry who will support your continued growth. You will learn from your fellow Engineers, Clinicians, Sales Leaders, and other industry professionals about our state of the art products.
What You Will Become: A highly influential driver who will be key in supporting clinical research studies for high impact results helping achieve our mission of delivering consistent high quality, safe and effective, regulatory compliant products and services.
What Success Looks Like:
- Assists with successful conduct of assigned studies consistent with the Clinical Strategy. This includes interfacing with representatives from key functional groups including Field Monitoring, Quality Affairs, Product Development, Manufacturing, Sales, Marketing, Customer Service, Regulatory Affairs, R&D, and European and US Clinical Groups
- Assists in preparation of study related material and training materials
- Assists with training of investigators, center staff and Spectranetics staff
- Works with Clinical Project Manager to develop plan to ensure device accountability for clinical sites
- Assists Clinical Field Specialists and Clinical Project Manager in obtaining all necessary documents from clinical sites prior to site initiation and updating documents as determined by needs and length of trial
- Reviews and verifies adequacy of center activation documentation
- Coordinates and conducts monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipts of accurate data and other required study documents
- Reviews monitoring reports and identifies discrepancies in reports and study files and ensures correction activities are completed
- Reviews clinical data/information and oversees data correction
- Assists Clinical Project Managers in providing interim and final reports and presentations
- Provides input to study budgets and project plans
- Works with the Clinical Project Manager to oversee the organization of the Master File and Site files for Clinical Trials
- Assists with second and third pass data entry as needed
- Performs Site Qualification, Monitoring, and/or Close-out visits as requested
- Performs audits of sponsor monitoring, sites files, CROs
- Assists Clinical Project Manager by providing sections of Investigational Plan or protocol as needed
- Assists Clinical Project Manager in writing sections of PMA Clinical Reports
- Takes initiative to oversee activities of Contract Research Organizations (CRO)
- Assists in the preparation of materials for CEC and DSMB meetings
- Assists in support of data validation and database closure as directed
- Position may require up to 30% travel, domestic and/or international
- Acquire professional, product and market expertise via independent reading, networking, and training
- Comply with applicable FDA and international regulatory laws/standards, company-wide and departmental Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs)
- Perform related duties as assigned
Required Knowledge and Skills:
- Ability to work effectively with cross functional teams
- High attention to detail and accuracy.
- Advanced written and oral communications skills.
- Able to manage multiple tasks independently
- Able to identify problems, develop solutions and implement to address study issues
- Proficient knowledge of medical terminology, disease states and current treatment modalities
- Expertise with GCPs and regulatory compliance guidelines for clinical
- Knowledge of clinical and outcomes research study design, methods and statistics.
- Bachelor's degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field.
- Masters degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience.
- Minimum 4-5 years experience directly supporting clinical research or similar experience in a medical/scientific area.
- Experience with mentoring others preferred
- May require up to 30% travel - must be flexible with travel to meet needs of the study
Agencies that submit a resume to SPNC must have a current executed SPNC Agency Agreement executed by a member of the Talent Acquisitions Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a SPNC Recruiter. All resumes must be submitted to the vendor portal under these terms or they will not be considered.
This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.
All applicants must pass a pre-employment drug screen to be hired.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or status as an individual with a disability.