Field Research Specialist
OneTrust
full-time
Posted on:
Location Type: Remote
Location: Remote • California, Florida, Illinois, Massachusetts, New York, Texas • 🇺🇸 United States
Visit company websiteSalary
💰 $94,000 - $151,800 per year
Job Level
Mid-LevelSenior
About the role
- Provides field support for clinical research related enrollment and procedures.
- Serve as a technology, protocol and clinical trial procedure expert and resource Abiomed stakeholders, physicians, and research personnel at the site.
- Develop and maintain in depth knowledge of clinical trial sites.
- Understand and assess investigators’ interests and qualifications.
- Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.
- Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel.
- Proactively and critically examine ways to enhance overall clinical trial performance.
- Facilitate communication between clinical trial sites and other Abiomed clinical staff (e.g., CRA, study team, Contracts Associate), as needed.
- Manage the following aspects of study progress, including, but not limited to: Start Up Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.
- Facilitate contract/budget escalations as part of the start-up process.
- Train facility staff regarding protocol requirements and technology.
- Develop site-specific strategies to promote appropriate patient enrollment.
- Identify site successes and challenges and assist in implementing troubleshooting techniques that promote study goal achievement.
- Provide ongoing feedback concerning all aspects of study progress, specifically enrollment and procedure related, for the purpose of developing and implementing strategies that will optimize patient safety and contribute to organizational and corporate goals/objectives.
- Provide support for all study-related aspects to research partners, including but not limited to the following questions: technical, protocol, standard of care, clinical trial reimbursement, etc.
- Provides on call, bedside case coverage for multiple clinical trials and clinical trial sites.
- Provides back up support in the following areas, trouble shooting, in-service training to physicians and healthcare professionals.
- Responsible for product reporting and troubleshooting with customers and field personnel within the clinical research portfolio.
- Collaborate with and provide feedback to Clinical Scientists and study teams in the development of clinical study deliverables, such as protocol design, source documentation, work instructions, patient recruitment materials and product training.
- Identify and communicate best practices relevant to clinical trial execution.
- Seek opportunities to continue demonstrating and developing technical, research, and organizational leadership qualities.
- Collaborate with Clinical Affairs, Medical Affairs, R&D, marketing, and commercial teams to support and advance key projects.
- Serve as a scientific interface with healthcare professionals.
- Act as resource in corporate product education as it relates to investigative technologies, as necessary.
- Develop collaborative cross-divisional team relationships.
- Provides engineering, education and clinical support in response to field-based inquiries on as needed basis.
- Transfers clinical trial knowledge and experience into meaningful input and feedback to cross functional partners in R&D, medical affairs, marketing, sales, and education.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Requirements
- Bachelor’s degree in engineering, nursing, biological sciences, a related field, equivalent or related certification in cardiology
- Typically, a minimum of 5 years of relevant clinical experience, with in-depth knowledge of cardiology, and related cardiovascular technologies
- Direct patient support in Cath lab and operating room is a plus
- Availability for to work on call for emergent clinical trial support required
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to leverage and/or engage others to accomplish projects
- Advanced verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Exceptional presentation and influence skills
- Required clinical research experience in medical devices
- Knowledge of Good Clinical Practices and trials, including feasibility IDE
- Multitasks, prioritizes, and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to travel approximately 70% domestically.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchcardiologyclinical trial procedurespatient enrollmentprotocol designsource documentationclinical trial reimbursementGood Clinical PracticesIDEtroubleshooting
Soft skills
communicationpresentation skillsinfluence skillsorganizational skillsattention to detailmultitaskingprioritizationcollaborationleadershiprelationship management
Certifications
Bachelor’s degree in engineeringBachelor’s degree in nursingBachelor’s degree in biological sciencesrelated certification in cardiology