Clinical Research Coordinator

Location
Rockville, Maryland
Posted
May 07, 2022
Ref
2022-11617
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

We are currently searching for a Clinical Research Coordinator to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD.

 

Duties & Responsibilities
  • Facilitate working groups to collaborate and write project specific SOPs, work instructions and other documents to develop and harmonize operational processes. Identify new processes, build teams, lead working group meetings, develop and negotiate ideas from concept to written approved process.
  • Provide document management (document control) support. Includes participation in the development of organized system tools for tracking of specific clinical trial documentation received and by program quality assurance.
  • Support the Quality Assurance Manager in the development and implementation of the Division’s electronic Clinical Quality Management System (Master Control).
  • Participate in quality assurance activities related to the close out of projects (such as file audits, tracking, reconciliation and transfer of clinical documents into long term archival facility).
  • Provide administrative support to the COR (Contact Officer Representative) who is responsible for management of the Regulatory Contract in ensuring compliance with requirements of the contract (e.g., reviewing quarterly progress reports and other deliverables).
  • Perform quality assurance review of Office of Regulatory Affairs documents to include (but not limited to) contract agreements, audit reports, and other related clinical documents.
  • Attend and assist in the planning and facilitation of Office of Regulatory Affairs team meetings.
  • Coordinate the development of various QA related metric reports.
  • Assist in the management of Division contract records.
  • Tasks include the following:
    • Upload documents and input key information (such as agreement status, program, drug information) into the Clinical Trial Agreement Livelink database.
  • Reconcile information stored in the database with corresponding hard copy records.
  • Generate contract (clinical trials agreements, confidentiality agreements, etc.) tracking numbers and templates from the database to provide to staff.
  • Generate metric reports (from database) related to the contract agreements tracked in the database.
  • Provide status updates to team members regarding agreement status and disposition.

#LI-DD1

Requirements
  • Bachelor’s degree in a related discipline.
  • Minimum of five (5) years of experience in clinical research or a related field.
  • Knowledge of clinical quality management and systems (such as Veeva, Master Control, etc.) is preferred.
  • Excellent communication, grammar and writing skills required.
  • Demonstrated superior knowledge of research protocols and clinical, scientific and/or medical terminology.
  • Demonstrated superior experience with data collection.
  • Demonstrated experience with Microsoft Office (Word, Excel, etc.).

 

 

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.