Training\/Archivist Administrative Assistant
Pharmaron

We are looking for an Administrative Assistant to join our team (full-time, onsite in Baltimore, MD), focused on supporting our clinical research team by maintaining and organizing training documents. May support quality and regulatory department to managing and maintain the clinical trial records and archives as needed.

Day-to-Day

• Maintaining and organizing training documents, including tracking completion of training requirements and updating training records.
• Assisting with the preparation and distribution of training materials and presentations.
• Providing support for training sessions, including coordinating logistics and providing administrative assistance.
• Maintaining and updating databases related to training documentation.
• Collaborating with team members to ensure training documentation is up-to-date and accurate.
• Providing support for audits and inspections related to training documentation.
• Responding to inquiries from team members and providing guidance on training documentation.
• May help to maintain effective systems for organizing, storing, and retrieving clinical trial records and archives.
• When assigned, may support quality and regulatory to ensure that all clinical trial records and archives are maintained in compliance with GCP guidelines and regulations.
• May assist with the preparation of regulatory submissions by providing requested clinical trial records and archives.
• Helps to maintain accurate and complete records of all clinical trial data, including patient information, study protocol, informed consent forms, case report forms, and other related documents.
• Assists to ensure that all clinical trial records are securely stored and preserved for future reference.
• Helps to perform regular audits of clinical trial records and archives to ensure compliance with GCP guidelines and regulations.

• HS Diploma or equivalent, required. Associate or Bachelor's preferred.
• 2 years of work experience in a clinical environment strongly preferred
• Good Laboratory Practices (GLP) - a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
• Good Clinical Practice (GCP) - quality standards that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects.
• Excellent organizational and time-management skills.
• Strong attention to detail and ability to work accurately in a fast-paced environment.
• Ability to work independently and as part of a team.
• Good verbal and written communication skills.
• Familiarity with regulatory requirements for clinical trial records and archives.
• Proficiency in Microsoft Office and other relevant computer applications.