In House Clinical Research Associate
Hays

Bethesda, Maryland

This job has expired.


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.

An American Company is seeking a In House Clinical Research Associate in Bethesda, MD.

Role Description

The In-House Clinical Research Associate is responsible for supporting clinical study teams, primarily the field CRAs and the Project/Task Manager, as required on clinical trial administrative duties. Duties may include but are not limited to:

• Assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation
• Coordinate or assist in distribution of trial-related materials to study sites
• May assist in preparing the Site Initiation Visit presentation or review of clinical monitoring plans
• Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file held by TRI or Sponsor/Client
• Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs
• Track essential regulatory documents in a centralized web-based system and/or another database
• Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems

Skills & Requirements

• Bachelor's Degree in life sciences or another health-related field
• Clinical trials /human subjects research experience with at least some knowledge of FDA/ICH GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO environment (e.g.,
• In-house CRA, Study Coordinator, IRB Coordinator, Regulatory Coordinator/Associate): 1-3 years (preferred)
• Understanding of medical and clinical trials terminology
• Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution
• Able to work independently or with minimal supervision as well as within a team
• Excellent attention to detail with organizational and prioritization skills for efficient productivity
• Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum)
• Excellent professional writing and verbal communication skills (position requires clear phone and email communication)
• Able to multi-task during the review/processing and preparation of essential regulatory documentation
• Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right
• Must have excellent time management skills, able to adhere to strict timelines and expectations
• Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus
• Experience with using a Trial Master File, a plus

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the 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.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information.
#1143027


This job has expired.

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