Protocol Monitoring Specialist

Location
Bethesda, Maryland
Posted
May 26, 2022
Ref
2022-11814
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time

We are currently searching for a Protocol Monitoring Specialist to serve as an expert in providing quality assurance and compliance oversight to the research team. This position will liaison with the NINDS Quality Assurance and Data Management (QADM) Office and assist with tasks within the NINDS Division of Intramural Research.  This is a full-time, on-site opportunity in Bethesda, MD.  

Duties & Responsibilities
  • Track, organize and generate analyses and reports using available databases for evaluation of project needs.
  • Conduct site visits to monitor clinical trial progress.
  • Validate required documentation is being maintained.
  • Review site visit findings with investigator.
  • Assist in the preparation of new clinical trial protocols.
  • Serve as a Clinical Trials Specialist, with responsibility for carrying out administrative and information management functions for clinical trials and related research being conducted within the section.
  • Work with staff on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing.
  • Collaborate with staff on initial submissions, continuing reviews, amendments, audits and other administrative requirements.
  • Distribute and track all new clinical trial protocol documents to the protocol development team to ensure proper document control, through the initial draft until the final version prior to the start of a study.
  • Use and revise/create data capture forms to meet study needs.

 

#SOAR

#LI-FG1

Requirements
  • Master’s degree in Health and Medical Administrative Services
  • At least 3-4 years of experience
  • Clinical Research Associate (CRA)
  • Electronic Medical Records System
  • Electronic Data Capture System
  • SOPs
  • Site monitoring
  • Data Monitoring
  • Regulatory compliance
  • Data Integrity
  • Regulatory affairs
Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.