Senior Clinical Research Associate

The Sr Clinical Research Associate reports to the Director, Clinical Operations, BD Biosciences (BDB, and is responsible for ensuring the safety and efficacy of BDB products worldwide. This position is responsible for developing, executing and reporting clinical trials.  May work in a study management, monitoring, combination or a supporting role.  Capable of managing large programs, overseeing others, provide effective training, creating new processes, leading extended study teams, and performing audits of others within area of expertise.  Has full operational knowledge of local regulations and a good understanding of international regulations.

Complies with and has advanced knowledge of and application of BD policies and procedures. Advanced knowledge of BD and/or related products.  Expected to be extremely knowledgeable about design and conduct of most types of trials.  Expected to work internationally.  Demonstrates competency in management of external resources such as a CRO and/or central laboratory.  Is able to anticipate and prevent issues, and proposes potential solutions.  May guide the completion of major programs and may function in a project leadership role.  Reports to senior individuals within the Clinical Operations organization, and needs only limited supervision or oversight. Recognized internally as technical or subject matter expert in an area.  Represents Clinical Operations comfortably in a wide variety of internal and external settings.  May participate in cross-BD initiatives related to Clinical Operations. Ability to travel at least 35% of the time, mostly within the US but some international travel will be required.

• Develops and implements clinical plans for projects consisting of multiple studies in support of product design validation and claims.  Applies extensive technical expertise, and has deep knowledge of other related disciplines such as statistics and data management.


• Interprets and describes complex data. Creates complex, coherent, professional documentation such as clinical reports. May lead a team to compose draft manuscripts for publication.  Develops study and program resource plans and budgets.


• Interacts with the medical, data management and biostatistics departments in San Jose and will carry out all the work in line with the current San Jose procedures for clinical trials/performance evaluations..


• Represents BD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel.


• Excellent written and verbal communication skills, ability to create and organize technical/medical documentation and provide regular updates regarding the status and progress of the clinical studies.


• Preparation, management and monitoring of  simple to moderately complex clinical studies,


• Responsible for completing study preparation tasks, which include protocol; clinical department plans and CRF design support and ensuring adequate material/method management at the sites (e.g instrument(s), software and reagent(s) management for conducting the study as described in the protocol).


• Understands and adheres to requirements for study documentation and independently completes study documentation that is moderately complex in a professional and coherent manner.  May contributes and assist in development of manuscripts for publication with oversight. 


• Ensures availability of required supplies and/or resources for individual and/or group activities.     Has some effect on quality, cost, and/or productivity.  Provides input to a formal budget process.


• Is accountable for Clinical Operation decisions within BD as related to a specific discipline or project.  Interacts independently with clinical investigators and may interact with KOLs.


• Ensures availability of required supplies and/or resources for individual and/or group activities.     Has some effect on quality, cost, and/or productivity.  Provides input to a formal budget process. 


• Knowledge of ICH / Good Clinical Practices and other Regulations and/or Guidance's relative to the conduct of clinical trials worldwide


• Demonstrated ability to complete all aspects of clinical study development: preparation, conduct, and close-out. including:


• Assisting with the development of study materials such as manuals, annotated CRFs, monitoring conventions, tracking forms, monitoring tools, and other study materials.


• Qualifying, initiating and training site(s) in the test protocols. Demonstrated ability to train sites on technical systems. Facilitate preparation and collection of site level documents; review content to ensure consistency and regulatory compliance


• Conduct onsite, as well as, in-house monitoring/ review of Case Report Forms, study data files and instrument reports. Ability to conduct site close-out activities.


• Oversees training material development. Reviews training materials/ trains the trainer.  Mentors/ oversees site training / investigator meeting/provides feedback.


• Attend project team meetings as required. May serve as a resource for and interact with other functional areas to resolve site issues and facilitate project timelines