Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at CRM Headquarters . If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.
We are currently seeking a Clinical Trial Associate for the Hinckley, Ohio area.
Acts as the primary administrative point of contact for internal research staff and as the principle operational liaison for other research organizations.
Works with the Program/Project Manager(s) and subcontractors in the collection and consolidation of language and/or comments for study protocols for submission to Sponsor for review and/or approval.
Plays a key role in the organization of investigator meetings for clinical trials to include scheduling, content creation and/or review, logistics and communication.
Assists in the formatting of research protocols ensuring the correct template is being followed.
Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
Provides support for the tracking, photocopying, scanning and filing of clinical trial documents for the Trial Master File.
Assists with the creation and/or maintenance of study specific website.
Assists with preparation and/or submission of regulatory documents.
Maintains and updates contact lists (e.g. Clinical Project Managers, CRAs, monitors, data associates and data managers, investigational sites, external CROs, etc.).
Responsible for annual training and maintenance of training and compliance documents.
Arranges and participates in internal and external meetings and is responsible for meeting minutes when requested.
Provides all job-related status reports/technical reports as requested.
Supports Program Manager(s) and Project Manager(s) prepare and distribute administrative reports, including (but not limited to) internal and external status reports and scorecards.
Provides technical assistance to CRM Headquarters as needed.
Participates on proposal submission projects when requested.
Performs light duties and other related duties as required and assigned.
Bachelor’s degree in Life Sciences or a minimum of three years’ experience in clinical trials
Understanding of GCP guidelines for human research
Understanding of Code of Federal Regulations for Human Subjects
Computer Competency including proficiency in Microsoft Word, Excel and Powerpoint
Understanding Phases I-IV drug development processes
Minimum of two years’ experience in clinical research.
Must be able to work independently following a brief period of specific technical training.
Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.
ClinicalRM is an Affirmative Action-Equal Opportunity Employer
“NorthCoast 99” Best Places to Work recipient
Clinical Research Management - 16 months ago
ClinicalRM is a Contract Research Organization supporting government and commercial clinical research for biologics, drugs, and devices.