Job Description Summary

Job Description

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

About BD (Insert Department):

Medication Delivery Solutions (MDS), Medical Affairs

Position Summary:

The Principal Clinical Research Associate (Pr. CRA) is responsible for site management and monitoring of multiple complex studies and is the subject matter expert for group or platform of assigned clinical studies.  The Principal clinical research associate serves as the lead CRA on assigned projects and as mentor to other CRAs.  The person in this role performs assigned duties in compliance with Good Clinical Practices, and all Global, National and Local Regulations.  

Job Responsibilities:(Primary Duties, Roles, and/or Authorities)

Under the direct supervision of the Sr. Director Clinical Affair, the Pr. Clinical Research Associate (CRA) will provide supervising expertise to the project team and effectively run assigned clinical projects, by displaying confident understanding of CIPs (protocol) and study products.

The Pr. CRA will be assigned as a lead CRA on complex studies with responsibilities not limited to:

• Actively participates in the site feasibility and selection process.
• Authors Monitoring Plans and study source documents.
• Authors site-facing training materials and monitoring tools.
• Perform all types of on-site/virtual/remote/in-house monitoring activities and visits (e.g. qualification, initiation, monitoring, closure). 
• Conduct SDR/SDV per plan.
• Be responsible for and ensure site staff performs study conduct according to CIP (protocol) and in compliance with regulatory requirements/standards (GCP/ISO), IRB/EC policies and procedures, and BD-established standards.
• Prioritize patient safety is maintained and informed consent procedures are carried out and detailed accurately.
• Strictly maintain compliance with the company’s business travel and expense policies.
• Review/report AE/SAEs and protocol deviations per industry and BD standards.
• Maintain complete and audit-ready regulatory files for assigned site(s)/project(s) that comply with company and industry parameters, e.g. ALCOA.
• Ensure site(s) maintain an acceptable inventory of clinical supplies.
• Produce proficient and timely documentation of supervising activities/visits, e.g. timely and complete trip reports within company-specified quality standards.
• Proactively identify, call out, and handle risks and issues to ensure compliance.  Communicate internally and externally to ensure adequate knowledge sharing and operational continuity.
• Participate in extended functional team meetings, keeping the internal study team up to date on site status, issues, and risks.
• Maintain and properly close out site TMFs in a timely manner.

Education and Experience:

• Bachelor’s Degree or higher in a healthcare or science related field. 
• Five (5) years + of relevant clinical research experience as a field based CRA in the device/pharmaceutical industry, including a multi-phase business knowledge of medical device or pharmaceutical product development.
• Consideration of a candidate with any alternate level of education will be case-dependent based on experience and positional need.
• Experience with Medical Devices studies is highly desirable.
• Experience with Veeva Vault (CTMS and CDMS) platforms is highly desirable.

Knowledge and Skills:

COMPETENCIES:

• Professional conduct is a must.
• Fluent knowledge of spoken and written English language, including medical terminology
• Expert in presentation preparation and delivery
• Technical savviness with an ability to understand the impact technology has on growing efficiency and performance.
• Proficient in Veeva Vault CTMS and CDMS
• Solid understanding of clinical trial management processes and systems, including monitoring, investigational product handling, data management, etc.
• Solid understanding of domestic and international clinical research guidelines, such as ICH GCP, FDA CFR, ISO, HIPAA
• Work in a self-driven capacity, with limited need for oversight.
• Ability to build effective relationships with trial sites staff and colleagues.
• Excellent time management skills, with demonstrated ability for self-direction and initiation.
• Work with minimal supervision and has the ability to prioritize multiple tasks with competing timelines and deliverables.

Physical Demands: (if applicable)

Ability to travel ~10%

Work Environment: (if applicable)

This is a part-time contractual remote position.

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

Work Shift