Clinical Training Specialist

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The Emmes Company, LLC is searching for a Clinical Training Specialist. Emmes provides flexibility for this position in office location or home-based preference.

The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Project

This position will support The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) research team that provides data management and statistical support for clinical studies. To date, the efficacy of new treatments for drug addiction has been demonstrated primarily in specialized research settings, with somewhat restricted patient populations. To address this problem, the National Institute on Drug Abuse (NIDA) has established the National Drug Abuse Treatment (NDAT) Clinical Trials Network (CTN). The mission of the CTN is to forge partnerships to improve the quality of drug abuse treatment nationwide.

More information about the NIDA CTN can be found here: http://www.nida.nih.gov/CTN/Index.htm

Primary Purpose

The Clinical Training Specialist will support client training operations as outlined in customer contract facilitating the delivery of effective programs for substance use disorder clinical trials training, study-specific training, and other supportive training needs for the client/sponsor as required by the statement of work.

Responsibilities

Clinical Trials Training (Network training--broader focus)
  • Recommends training topics, solicits sponsor approval, and obtains network researcher feedback on scheduled webinars and training meetings
  • Issues presenter invitations, conducts presenter orientations for web meeting platforms, and facilitates communications with presenters and their staff
  • Facilitates webcasts, conference calls, and remote training, including recordings.
  • Reviews training materials for applicability to CTN audience, brand utilization, and documentation for completeness and applicability
  • Creates/edits presentations as needed
  • Maintains a repository of CTN training, and posts/collaborates with CTN Librarians to post session materials to the CTN training library

Study-Specific Training
  • Provides or facilitates training of clinical study teams on assigned protocol specific topics; consult on learning solutions
  • Schedules and attends/lead protocol training planning meetings (with the CSM and the Investigative Team members who are involved in training)
  • Ensures applicable training required by the CCC SOW are included in study training plans, including Regulatory and Documentation Requirements, Safety and Event Reporting, Laboratory Procedures, and Biological Assessments, Medication Management and Accountability, and Quality Assurance and Monitoring
  • Develops, finalizes, disseminates, and maintains the standard research Training Plan, the documentation form for training (TDF), and Site Staff Delegation of Responsibilities and Signature Log.
  • Facilitates web-based protocol training meetings
  • Provides direct input to National Training Meeting agendas and learning styles
  • Implements post training assessments and implements corrective action as determined by the Lead Investigative Team
  • Maintains a database of study-specific training completions, including training requirements, reports, and assessments
  • Maintains client website content for study documentation, such as protocols, MOPs, manuals, templates, and training materials, including presentations, handouts, study role aids, recordings, and narrated presentations

Additional Training Functions
  • Supports and maintains the GCP online training system, functions as liaison with the GCP website company, and ensures training compliance with GCP guidelines and regulations
  • Manages certifications for various research training; develops and maintains database to document and track training
  • Provides audit support through report generation of training quizzes, practica, and assessments
  • Maintains network training files, including relevant certificates and other training documentation
  • Evaluates training needs or gaps; recommends, develops, and implements training solutions.
  • Administers training website, refines content and collaborates with other experts to refine content of website to maintain currency
  • Collaborates with consultants and vendors on training related special projects including website redesign, content evaluation, maintenance, and e-learning opportunities
  • Identifies additional training activities and initiatives based on investigator needs or requests, seeking sponsor approval as necessary, and negotiates price; plans, implements, and monitors activity until completion
  • Contributes to the budget projections, tracks training related expenditures, reviews and processes invoices for approval and payment, and reports on actual costs; identifies and recommends solutions for cost savings and efficiencies
  • Writes abstracts, delivers oral presentations, and co-leads workshops on clinical research processes and training
  • Other duties as assigned.

Travel
  • May travel between corporate locations
  • Travel (20-30%) to investigator training meetings and attend conferences and annual sponsor meetings; travel will be applicable when travel commences post-COVID-19 travel hold

Experience
  • Bachelor's Degree in a training area or physical science area preferred or in lieu of degree, 10+ years of relevant experience accepted
  • Minimum of 5 years of relevant experience in training strategy, planning and support preferably in a in a biotech related area


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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