Senior Clinical Research Specialist / Principal Clinical Specialist

Job Description


Sr. Clinical Research Specialist
Redmond WA
Full time role

GENERAL SUMMARY:
Responsible and accountable for the management of all operational aspects of assigned internal and external clinical studies as directed by the Clinical and Human Factors Engineering Manager. Works closely with various cross-functional partners both internally and externally, including medical and scientific personnel. Leads the execution of clinical trials and cross-functional project team to ensure that all study operational activities are conducted efficiently and in compliance with all DHHS and FDA regulations and Corporate SOP’s.

MAJOR DUTIES/RESPONSIBILITIES:
• Plans and develops protocols for minimal risk Clinical Studies in collaboration with Medical Scientists.
• Oversees the conduct of investigational studies (IDE’s) and post market surveillance, as required and in accordance with FDA regulations.
• Acts as clinical liaison between Institutional Review Board and internal Regulatory staff to execute and conduct clinical studies.
• Collects and audits clinical data; prepares reports to communicate findings.
• Responsible for the preparation of protocols and Case Report Forms, finalization of monitoring and data management options (either in-house or contracted to a Contract Research Organization), IRB/Ethics committee approval, development of recruitment strategies to increase patient enrollment, the provision of clinical trial materials, and management of the trial, in collaboration with Medical Scientists.
• Ensure that all aspects of GCP or GLP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
• Establish and manage working relationships with CROs.
• Coordinates monitoring of all trials in an efficient manner by identifying and managing qualified support staff, establishing audit procedures and ensuring data integrity.
• Ensure the clinical research function runs efficiently and meets timelines by developing systems to track projects including all study, investigator and institutional review board information, patient recruitment activity and financial management.
• Responsible for the financial management of the clinical trial program including budget planning, resource allocation and preparation of quarterly reports.
• Trains and mentors clinical support staff in preparation of periodic meetings and study launches.
• Provides support to other organizational needs and objectives requiring clinical expertise.
• Collaborates with product development, regulatory, marketing teams, and external consultants.
• Works collaboratively with regulatory experts in the preparations of documents for regulatory submissions to FDA or other agencies world-wide.

Requirements   
BASIC QUALIFICATIONS:
• Bachelor’s degree or equivalent in medicine, nursing, science or related discipline.
• A minimum of 6 years of clinical research experience, including active independent field monitoring and site management.
• Completed the National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH) Good Clinical Practices (GCP) Training course within the past 2 years.
• Ability to review and evaluate clinical data.

PREFERRED/DESIRED QUALIFICATIONS:
• Experience in cardiology and cardiovascular medical device clinical research preferred.
• Prior supervisory experience of operations personnel (e.g. CRAs, consultants, etc.) and vendor management preferred.
• CRC and/ or CRA Certification
• Strong project management skills, including the ability to handle multiple assignments.
• Demonstrated efficiency in partnering with CROs and vendors.
• Experience managing project budgets.
• Proficient working knowledge of GCP, ICH, CIOMS, HIPAA and PHI laws, and regulations related to clinical trials.
• Proficiency in PC applications, including Word, Excel and Adobe Acrobat. Database and Visio experience a plus.
• Excellent organizational, interpersonal, negotiation and analytical skills.
• Good oral and written communication skills.

WORKING CONDITIONS:
• 10-50% travel required
• Fast-paced office environment, requiring significant (75%+) time using computer, mouse and telephone
• Class III Medical Device, highly regulated environment

Job Requirements




Principal Clinical Specialist
Redmond, WA
FTE

GENERAL SUMMARY:
The Principal Clinical Specialist provides clinical expertise in support of the design, development, manufacture and clinical application of a product, develops and implements design validation best practices and serves as an expert to the Clinical Affairs team, directly assists with data analysis and reporting for specific investigations related to assigned project or study and acts as a principle-level consultant to other functional groups regarding clinical issues.

MAJOR DUTIES/RESPONSIBILITIES:
• Demonstrate proficiency to corporate Quality System procedures and Technical Standards to ensure compliance with required class II and III medical device regulations.
• Develop User Needs Document as a basis for Design Validation.
• Provide input to, project plans, pre-Submission and 510(k) applications by, describing user needs, user characteristics, intended use and clinical application of products; develop operator product performance needs and usability goals; advocate the safety of devices for the operator and the patient.
• Participate in the development of safety risk analysis; identify system hazards, hazard severity and develop and validate mitigations; develop operator error hazard analysis.
• Determine whether product requirements specifications and user interface design and design documents adequately reflect user needs and intended uses.
• Plan, develop and conduct the design validation process, including usability protocols to demonstrate understanding of labeling or intuitiveness of product design, recruitment of external users for usability testing of product labeling and user interface, evaluation of product performance, documentation of findings, and participation in design reviews and other evaluations as necessary.
• Interface with customers for the development of use scenarios and user needs; establish customer and key opinion leader contacts for clinical use questions and as usability contacts.
• Review product related complaints related to potential adverse events or device malfunctions to determine whether or not the device use contributed to harm.
• Analyze data reports and summarize results pertinent to product design and usability.
• Provide input to and participate in post-production Complaint investigations and Corrective and Preventative Action activities.
• Plan and facilitate creation of operating instructions (manuals, labeling, quick reference labeling, operator installation/getting started instructions, in-service video and other user instructional or clinically-oriented literature) and evaluate accuracy and adequacy.
• Prepare documents for 510(k) submission, such as Certification of Summary of Adverse Safety and Effectiveness; Prepare Clinical Evaluation Report for Technical Documentation File to support CE Mark and other Regulatory documents as required.
• Plan and develop protocols for minimal risk Clinical Studies; work as clinical liaison between Internal Review Committee and internal Regulatory staff to execute procedures and conduct in-house clinical studies.
• Plan, develop and conduct investigational studies (IDE’s) as required, in accordance with FDA regulations.
• Plan and conduct post market surveillance; collect and audit clinical data, interpret results and prepare reports to communicate findings.
• Assist with data collection for specific research activities.
• In collaboration with Product Managers and Clinical Marketing, assist in the development of customer, sales and service training materials.
• Provide support to marketing and engineering for customer issues.
• Perform other related duties as assigned.
Requirements    BASIC QUALIFICATIONS:
• Bachelor’s degree in Nursing and 6+ years’ critical care and/or emergency nursing experience.
• AHA ACLS current or prior provider status required and recommended to be maintained.
• Equivalent combination of education and experience is acceptable.
• Minimum of 2 years in a clinical function within a medical technology, biotechnology, pharmaceutical or related corporate experience.
PREFERRED/DESIRED QUALIFICATIONS:
• Current RN license.
• Prior medical device product development, including embedded software experience, preferred.
• Prior software/web application development preferred.
• Excellent organizational, interpersonal, negotiation and analytical skills.
• Excellent verbal communication skills.
• Demonstrated skills in critical care monitoring techniques; ECG rhythm interpretation skills.
• Ability to compose and edit technical and clinical documents for regulatory submissions.
• Ability to collaborate with a variety of functional areas, from Marketing to Engineering.
• Proficiency in PC applications, including Word, Excel and Adobe Acrobat. Database and Visio experience a plus.

WORKING CONDITIONS:
• <10% travel required (domestic and international)
• Fast-paced office environment, requiring significant (75%+) time using computer, mouse and telephone
• Class III Medical Device, highly regulated environment


Job Snapshot

Other Pay Competitive
Employment Type Full-Time
Job Type Information Technology
Education Not Specified
Experience Not Specified
Manages Others Not Specified
Industry Employment - Recruiting - Staffing
Required Travel Not Specified
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Senior Clinical Research Specialist / Principal Clinical Specialist


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