Clinical Training Specialist - Remote

Location
Rockville, Maryland
Salary
Competitive
Posted
May 11, 2022
Closes
May 19, 2022
Ref
3265
Function
Administrative
Industry
Science
Hours
Full Time
US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

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 in the area of substance use disorders. NIDA has established the National Drug Abuse Treatment (NDAT) Clinical Trials Network (CTN) whose mission it is to forge partnerships with treatment researchers and community-based providers to improve the quality of drug abuse treatment nationwide. 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. This will primarily involve training designed for staff working at the research sites implementing the substance use studies, as well and other training, all described in more detail below.

Responsibilities

Clinical Trials Training (Network training--broader focus) Involves facilitation of a national training webinar series designed for all staff across all CTN studies, on general topics of interest in the areas of clinical trial development and implementation and substance use.
  • Solicits ideas for training topics, 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
  • Edits presentations as needed or may assist presenters in preparation of their slides
  • Maintains a repository of CTN training, and posts/collaborates with CTN Librarians to post session materials to the CTN training library

Study-Specific Training

Involves facilitation of the training for the research staff (e.g., Nurses, Research Assistants, Medical Clinicians, Principal Investigators) working on a specific clinical trial.
  • Provides or facilitates training of clinical study teams on assigned protocol specific topics; consult on learning solutions
  • Schedule and attend/lead protocol training planning meetings (with the Clinical Study Manager and the Investigative Team members who are involved in training)
  • Ensures applicable training required by the Clinical Coordinating Center's (CCC's) SOW are included in study training plans. Some topics may include Regulatory and Documentation Requirements, Safety 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
  • Tracks 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.

Experience
  • Bachelor's Degree in a training area or physical science area preferred with 3 years of relevant experience in clinical research and/or training, planning and support in a biotech related area preferred, in lieu of degree, 7 years of relevant experience accepted
  • Strong verbal and written communication skills
  • Organized, detail oriented, flexible, responsible
  • Adept at Microsoft Office Suite products
  • Meeting facilitation

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Unlimited Approved Leave


  • Tuition Reimbursement


  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


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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.

Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.