Sr. Clinical Research Specialist
Full time role
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.
• 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.
• 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.
• 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.
• 10-50% travel required
• Fast-paced office environment, requiring significant (75%+) time using computer, mouse and telephone
• Class III Medical Device, highly regulated environment