The Sr. Clinical Research Associate will manage and oversee the human, material, system and fiscal resources to provide clinical document management, contract services and/or other clinical operations required activities across studies and programs.
General Description and Duties:
To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Support implementation and management of key standard processes that lead to positive and measurable impact for clinical programs including clinical studies (e.g. quality, efficiency, consistency)
- Handles routing of contracts and single case agreements for signature and distributes to key stakeholders in timely manner.
- Strong understanding of contract structure and terms.
- Strong understanding of the structure and nature of Institutional Review Boards (IRB’s).
- Ensures IRB documents are maintained and up to date.
- Ensures contracts are loaded timely and accurately into both shared drive and Contract Management System.
- Responsible for overall contract document maintenance.
- Track and report on high performance standards and metrics for quality oversight of applicable clinical operations including clinical studies and related activities for assigned staff.
- Can manage process for execution of R & D contract activities per implemented policies, procedures and processes.
- Can manage and execute site initiation, maintenance and closures for clinical studies.
- Ensure collaboration with engagement owners and cross-functional stakeholders to facilitate contracts execution.
- Ensure collaboration with engagement owners and cross-functional stakeholders to facilitate clinical study execution.
- Can manage process for submission and archiving of essential study documents.
- Can manage process for engagement specialist activities involved with HCP engagements according to implemented policies and procedures.
- Can manage process for execution of other clinical operations processes as assigned.
Projects and Other Duties:
- Performs other duties as assigned.
- Travel time ~ 30%.
- Strong communication skills, both written and oral required to research, identify root cause by communicating at various levels within the organization, consolidating the issues, and sharing the resolution.
- Strong organization skills required to manage and prioritize work including multiple priorities at the same time. Tracking and communicating current workload and open issues on a regular basis to key stakeholders and leaders.
- Bachelor’s degree in a relevant discipline
- 3 years in medical device Clinical Research role, Class II or III devices preferred.
- Experience reviewing clinical research contracts and contract document maintenance.
- 3 years of experience in the conduction of clinical trials/studies.