DC
Duke CareersSenior Clinical Research Specialist
Clinical Research Specialist supporting clinical research operations at Duke University School of Medicine. Involves data management, participant recruitment, and compliance with study protocols.
About the role
- Lead coach and mentor field research specialists to achieve organizational, clinical, and study goals and milestones.
- Foster a culture of accountability, innovation, collaboration, and continuous learning and improvement.
- Provide coaching, feedback, and professional development opportunities.
- Ensures continuous professional growth and alignment to organizational priorities and values.
- Oversee field team activities related to site engagement, case support, and coverage, enrollment support, rapid resolution of field challenges, and protocol adherence.
- Serve as a technology, protocol and bedside clinical trial procedure expert and resource Abiomed stakeholders, physicians, and research personnel at the site.
- Provides engineering, education and clinical case support in response to field-based inquiries on an as needed basis.
- Provides on-call clinical case coverage for multiple clinical trials and clinical trial sites.
- Provides back up support in the following areas, troubleshoot in-service training to physicians and healthcare professionals.
- Partner with investigators, coordinators, and research staff to remove barriers and optimize performance.
- Translate field feedback and operational data into actionable business intelligence for leadership.
- Identify emerging technologies, digital tools, and process improvement that advance field execution and research outcomes.
- Lead innovation and new engagement models that enhance the sponsor investigator relationship and improve trial performance.
- Monitor study progress, identify risks, and implement corrective action plans.
- Serve as primary liaison between the field research team, clinical operations, and study leadership.
- Represent the Field Research Team in cross functional planning, steering committee, and executive reviews.
- Collaborate cross-functionally with medical, data, and regulatory teams to ensure alignment.
- Collaborate with Clinical and Product Training and Education to prepare for market launch of new products and product improvements
- Works with Product Management and Engineering to create training materials on new products and product updates
- Works closely with Abiomed’s field team.
- Establish key performance indicators (KPIs) and track team performance.
- Analyze site level data to identify trends, share best practices, and drive improvements.
- Ensure compliance with GCP, SOPs, and regulatory requirements.
- Build and nurture strong relationships with external partners to drive future clinical trial success.
- Lead strategic initiatives, expanding existing partnerships and exploring new marketplaces.
- Perform clinical quality reviews of criteria and workflows.
Requirements
- Bachelor’s degree required: advanced degree preferred MBA, MSN, DNP, APN
- 5+ years of clinical research experience, field operations, medical device trials after clinical training in related field.
- Strong knowledge of clinical trial operations, site management, and regulatory requirements.
- Proven track record and ability to lead, motivate, and develop field-based teams.
- Excellent communication, presentation skills, problem-solving, and relationship building skills.
- Passion for innovation, team development, and patient centric research.
- 70% Travel Required.
- Core Competencies Strategic thinker with operational focus.
- Collaborative leadership style with a focus on team empowerment.
- Leadership and talent development.
- Innovation mindset.
- Results driven with strong attention to detail and follow through
- Adaptability in a fast paced and evolving environment
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave – 10 days
- Volunteer Leave – 4 days
- Military Spouse Time-Off – 80 hours
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