Dermatology Clinical Research Manager

1 week ago


Maine, United States Lifelancer Full time

About the Job

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This is a home-based position in the USA supporting the Midwestern/North Central Regions of the United States. We are looking for an experienced Senior Clinical Research Associate (CRA) to join our team. As a Senior CRA, you will be responsible for monitoring the progress of clinical studies at investigative sites or remotely, ensuring that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

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About You

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  • You have at least 5 years of experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry.
  • You have a strong understanding of ICH/GCP standards and applicable regulatory requirements.
  • You have excellent verbal and written communication skills in English.
  • You have the ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines.

Job Responsibilities

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  • Conduct site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulations.
  • Participate in investigators' meetings.
  • Prepare site visit reports and follow-up letters to the investigator.
  • Build productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets.
  • Perform source data verification, ensure on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate.

Lead CRA Responsibilities

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  • Review and approve site visit reports.
  • Track site visit and trip report metrics and escalate issues to project teams.
  • Recommend potential solutions to identified issues and work with the project managers to find resolution.
  • Support the development of annotated site visit reports, clinical monitoring plans, and monitoring tools.
  • Support the preparation and development of materials related to the training of CRAs.
  • Mentor CRAs.
  • Conduct on-site quality control visits with CRAs.

Our Company

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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.

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We Offer

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A competitive salary of $80,000 - $110,000 per year, depending on experience, plus benefits including medical, dental, and vision insurance, 401(k) matching, and paid time off. Regular travel, which may include overnight trips and/or international travel, is required as part of this role.

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Lifelancer

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Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.



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