Clinical Trainer

Tech Cambridge, MA Raleigh-Durham, North Carolina Cambridge, Massachusetts Plymouth Meeting, Pennsylvania


Description

Position at ConcertAI

Company Overview

ConcertAI’s mission is to accelerate insights, advance research, and improve patient outcomes in oncology and across life sciences. ConcertAI’s leading real-world evidence, AI technology and software-as-a-service solutions support healthcare decision-making across clinical research & development through commercialization. Top biopharma sponsors, clinical research organizations, healthcare providers and institutions rely on ConcertAI’s evidence-generation and digital transformation capabilities to advance precision medicine and medical innovation.

 

ConcertAI has emerged as one of the fastest growing AI health tech companies backed by industry-leading private equity companies: SymphonyAI Group, Declaration Partners, Maverick Ventures, and AllianceBernstein PCI.

 

Role Summary

ConcertAI is a fast-growing healthcare research organization, leading the market in oncology healthcare data analytics. We are assembling a talented team to join us on our mission to transform how clinical insights are generated and to accelerate therapeutic innovations to patients. Our dynamic, fun, and highly experienced team is looking for a Clinical CRO/Sponsor Trainer or someone with similar clinical research, ICH-GCP, and clinical software systems training experience to join our expanding team.

 

Clinical Center of Excellence (COE) Trainer on the ConcertAI Clinical Developmental Technologies (CDT) team assesses the educational needs and competencies of internal staff and develops, schedules, coordinates, and conducts training for new and existing staff within the clinical development technology team, implements and continually updates a comprehensive clinical research training curriculum. The CDT Trainer works under the direction of the Clinical Development Technologies (DCT) Senior Director, Head of Operations and Delivery and works closely with the Center of Excellence team to ensure clinical research expertise is a core competency of the CDT team.

 

Responsibilities

  • Define and develop clinical research training programs, including outlines, goals, content, and knowledge assessments as needed.
  • Create and administer knowledge assessments to assess knowledge gaps and determine employee comprehension.
  • Evaluate course content on a periodic basis and update in accordance with regulatory guidance and regulations.
  • Collaborate with functional departments to determine additional clinical research training needs.
  • Liaise with subject matter experts as needed to develop training appropriate to projects.
  • Support development of external client training and enablement activities to include building modules, webinars, and content for internal and external audiences.
  • Collaborate with product teams on new releases and distribute, communicate, and train stakeholders on new or changed features.
  • Collect and manage customer feedback related to product enhancements and improvements.
  • Design and implement interactive, competency-based computer-based training programs.
  • Develop target-audience appropriate quality assurance components for all training programs.
  • Present training programs using recognized training techniques and tools.
  • Maintain audit-ready electronic training records.
  • Design, implement and distribute a quarterly newsletter to feature regulatory updates, software enhancements, and other educational topics.
  • Provide feedback to manager on any issues related to training.
  • Evaluate and make recommendations on changing and updating training material and methodology.
  • Act in accordance with federal healthcare privacy laws and regulations, including HIPAA, HITECH and 21 CFR part 11 (GxP)

 

Requirements

  • Bachelor’s degree
  • Five to seven years of experience working in clinical research required
  • Three to five years of clinical research training experience, CRO and/or pharmaceutical industry experience required
  • Advanced knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP
  • Oncology experience is preferred
  • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
  • Excellent written and verbal communication, presentation, and people management skills
  • Excellent organizational and time management skills
  • Pragmatic and willing to drive and support change
  • Comfortable with ambiguity
  • Supportive of a culture of continual improvement and innovation; promote knowledge sharing
  • Able to work successfully in a diverse team environment
  • Advanced computer skills are required; Comfort with technology, and willingness to learn new software is required
  • High proficiency with MS Office
  • Some travel may be required

 

Learn More About ConcertAI

Our team at ConcertAI is dedicated to transforming healthcare decision-making through the application of RWE and AI to improve patient outcomes. We work in a fast-paced, dynamic, high-performing culture where diversity, collaboration, and innovation are valued. Join us on our quest to create a world free of disease. Learn more about ConcertAI at www.concertai.com , or follow us on LinkedIn. 

 

EEO

ConcertAI provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.