The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
A Biotechnology Company is seeking a Clinical Research Associate I in Rockville, MD.
Role Description
The Clinical Research Associate I (CRA1) supports and coordinates the logistical aspects of clinical trial management, site management, data review and cleaning according to FDA regulations, Good Clinical Practice (GCP) and relevant SOPs and acts as a pivotal point of contact for the clinical trial team. Under general supervision, the incumbent will assist with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned. Although prior CRA experience is not essential, a working knowledge of the clinical trial process and associated regulations, responsibilities, and roles are required.
• Under moderate supervision, supports and coordinates logistical aspects of clinical trials
• Assists in the development and editing of study-related materials (e.g. consent forms, study binders, site study aids)
• Assists with preparation of training workshops, Investigator/Advisory Board meeting materials
• Assists with all phases of clinical trial activities (e.g. start-up, conduct, and close-out)
• Develops study tracking tools (e.g. site lists, enrollment tracking, vendor spreadsheets)
• Maintains tracking spreadsheets/databases and provides routine reports/dashboards to study team members
• Requests PO independently, may review invoices with oversight from Clinical Project Manager (CPM)
• Tracks essential documents and maintains/reviews the eTMF under the guidance of CPM.
• Assists with management of investigational product and study supplies by ensuring the accuracy of shipments of study-related materials and collection of regulatory documents required for IP release
• May attend co-monitoring visits or other site visits based on experience and training provided by and under guidance of CPM or designee
• Assists the CPM with the review of clinical database and management of flow of data, including but not limited to facilitating resolution of queries
• Assists with collection, review and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 reports)
• Assists with filing and management of the Electronic Trial Master File (eTMF)
• Distributes meeting's agenda, prepare and distributes final meeting minutes including documentation of action items
• May assume a specialized administrative role (e.g. SOP Administrator)
• Travel up to 5% of the time is required
Skills & Requirements
• BS degree with minimum of 2 years relevant industry experience or MS degree with minimum of 1-year relevant industry experience
• Broad understanding of drug development and cross-functional interactions
• Demonstrate core understanding of medical terminology or clinical trial activities
• Able to help develop clinical trial documents with moderate oversight
• Working knowledge and familiarity with all aspects of clinical site management, monitoring, and oversight
• Knowledge of principles and practices of computer applications, including data management and data review
• Must display strong analytical and problem-solving skills
• Proficient in TMF and regulatory document knowledge
• Ability to effectively manage and communicate information and updates to relevant stakeholders
• Good collaboration skills and ability to work effectively as part of a team
• In-depth knowledge of ICH-GCP and its application to clinical trials
• Advanced knowledge of Word, Excel and Power Point and Outlook
• Ability to navigate in ambiguity
• Ability to establish priorities, excellent sense of urgency to manage multiple tasks and deadlines
• Attention to detail
Why Hays?
You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
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Hays is an Equal Opportunity Employer.
Drug testing may be required; please contact a recruiter for more information. #1118249
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