On-Site Clinical Research Associate
- Employer
- Sparks Group
- Location
- Bethesda, MD
- Closing date
- Jun 15, 2019
View more
- Industry
- Research
- Function
- Administrative, Other
- Hours
- Full Time
Job Details
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!
Responsibilities:
- 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.
Qualifications/Background Profile:
- 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.
Company
Bringing the Best People and the Best Companies Together Since 1970.
Sparks Group (formerly SPARKS, Sparks IT Solutions, and Sparks Personnel) is the Washington DC Area's leading temporary staffing and full-time recruiting services provider. Whether you are seeking your next opportunity or looking to add talent, Sparks Group is the ideal partner for you! Each of our four divisions (Sparks Office, Sparks Accounting & Finance, Sparks IT, and Sparks Creative) specializes in placing professionals in temporary/contract, temporary-to-full-time, and full-time roles across a diverse array of staffing categories, positions and levels including: office/administrative, customer service, human resources and talent acquisition, legal support, government and cleared personnel, mortgage/banking, accounting and finance, contracts and procurement, information technology and creative/marketing.
Sparks Group brings over four decades of experience placing professionals in challenging and rewarding positions at many of the area’s most prestigious organizations. Our primary focus is presenting opportunities that match each candidate’s skill-sets, experience levels, career objectives, and growth needs. Sparks Group has regularly ranked as one of the top US staffing and recruiting firms having been named to Inavero’s Best of Staffing Lists® for Client and Employee Satisfaction (2012-2017). Additionally, Sparks Group is proud to have been recently selected for other awards Staffing Industry Analysts’ 2017 Best Staffing Firms to Work For, Washington Business Journal Best Places to Work (2017), the Washington Post’s Top Workplaces® List (2017, 2014), Forbes® Best Professional Recruiting Firms (2017), and the National Capital Business Ethics Award.
- Website
- http://www.sparksgroupinc.com/
- Telephone
- 3012792300
- Location
-
700 King Farm Blvd.
Suite 100
Rockville
MD
20850-5736
US
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