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- Westlake, MD 20817
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On-Site Clinical Research Associate
Sparks Group • Westlake, MD
Posted 2 months ago
Job Summary/Company:Sparks Group has Partnered with a growing CRO seeking to add new clinical research associates to their team to support new clinical trials! The Clinical Research Associate is responsible for supporting clinical study teams as required on clinical trial administrative duties. If you are seeking to start a new career in the clinical realm, apply below and call 301-926-7800 for more information!
- 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).
- 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 other database.
- Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems.
- Bachelor’s Degree in life sciences or another health-related field required.
- Bilingual in Spanish a plus
- Previous experience with clinical trials /human subjects research.
- Knowledge of FDA/ICH GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO environment One to three (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.
- Excellent MS Word, Excel and Outlook skills required.
- Excellent professional writing and verbal communication skills
- 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 required
Qualified candidates should send their resume AND call Sparks Group for additional details. Please note, resume must include a valid email address in order to be considered. We look forward to discussing your background, your current job search, and your potential career path with Sparks Group!
Sparks Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, pregnancy, citizenship, family status, genetic information, disability, or protect veteran status.