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Clinical Monitoring Trainer (US)

extra holidays - extra parental leave
Remote: 
Full Remote
Contract: 
Work from: 
North Carolina (USA)

Offer summary

Qualifications:

Over 5 years experience in clinical research as a CRA or CTM in the biotechnology, pharmaceutical, and/or CRO industry, Bachelor degree in relevant field or equivalent experience, Deep understanding of ICH/GCP standards, regulatory requirements, and CTMS systems, Excellent English communication skills.

Key responsabilities:

  • Developing and delivering training to Clinical Monitoring team members
  • Assessing training effectiveness and identifying further training needs
  • Providing mentorship and support to new and existing team members
  • Accompanying CRAs for observation and evaluation visits
Innovaderm Research Inc. logo
Innovaderm Research Inc. Pharmaceuticals SME https://www.innovaderm.com/
201 - 500 Employees
See more Innovaderm Research Inc. offers

Job description

The Clinical Monitoring Trainer is is responsible for creating and delivering training to Clinical Monitoring team members such as CRAs, CTMs, Site Visit Report Reviewers, Central Monitors, and Clinical Trial Assistants **

This role will be perfect for you if:**

  • At least 5 years of years experience working in clinical research as a CRA or CTM in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry;
  • Strong communication skills in English
  • Experience in developing and delivering training to clinical operations team members
  • Capable of evaluating the effectiveness of trainings provided and to identify the training needs

Responsibilities

More specifically, the Clinical Monitoring trainer must:

  • Creating and delivering group and individual systems training to new hires in the Clinical Monitoring Department (e.g. CTMS, eTMF, time and expense reporting, Innovaderm SharePoint & intranet, etc.) as well as providing on-going support to team members.
  • Creating and delivering group and individual training on ICH-GCP, regulations, SOPs and monitoring principles for new and existing team members.
  • Serves as a mentor and point of contact for new and existing team members.
  • Accompanies CRAs on site or remotely for observation and evaluation visits.
  • Assists in the development of training plans for new hires.
  • Follows-up with new hires to ensure that administrative trainings are completed in a timely manner and documented

Requirements: **

IDEAL PROFILE**

Education

  • Bachelor degree in a field relevant to clinical research and/or equivalent experience;

Experience

  • At least 5 years of years experience working in clinical research in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry;
  • Experience in dermatology an asset;

Knowledge And Skills

  • Profound knowledge of ICH/GCP standards and applicable regulatory requirements;
  • Prior experience with different CTMS, eTMF and EDC systems
  • Very good presenter/teaching skills;
  • Proficient in English (excellent oral and written);
  • At least 5 years of years experience working in clinical research in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry;
  • Ability to prioritize different assignments and work under pressure while maintaining attention to detail, accuracy in work, and meeting timelines;
  • Excellent judgement and problem-solving skills;
  • Strong organizational, communication, time management and multi-tasking skills;

Our company: **

Work location**

This position may be home-based in the United States, Canada, or office-based in our Montreal headquarters. Occasional travel may be required. **

The work environment**

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

  • Flexible work schedule
  • Full-time position
  • Employee benefits (medical, dental, vision, vacation, sick days)
  • Ongoing learning and development

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

Innovaderm is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, gender, gender identity or expression, sex, genetic information, marital status, national origin, race, religion, protected veteran status, sexual orientation, citizenship status, individuals with disabilities or other characteristics protected by law.

Innovaderm only accepts applicants who can legally work in the United-States.

Required profile

Experience

Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Decisiveness
  • Time Management
  • Problem Solving
  • Multitasking
  • Verbal Communication Skills
  • Organizational Skills
  • Collaboration
  • Teamwork

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