Clinical Operations Coordinator

Location
Rockville, Maryland
Posted
Apr 24, 2022
Ref
2022-11498
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time

We are currently searching for a Clinical Operations 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
  • Provide project management for the day-to-day protocol registration (PR) activities including but not limited to, coordinating and leading meetings, and discussions regarding all aspects of protocol registration.
  • Serve as the main point of contact for all protocol registration activities for the division.
  • Serve as the primary reviewer of all protocol registration deliverables including but not limited to standard PR reports, PR notification messages, review and recommend approval to Federal Client of all Investigator or Records, and Clinical Research Site regulatory documentation that include IRB/EC documentation, Forms FDA 1572/DAIDS IoR Forms, and site-specific informed consent forms to ensure all applicable regulations are met.
  • Serve as the co-lead for working groups and committees to communicate information regarding protocol registration policies and requirements.
  • Manage and design all protocol registration-related trainings for the division, including but not limited to e-training modules and present proposals/materials to the PR Team Leader for approval prior to implementation.
  • Evaluate and identify issues that are or may be problematic related to protocol registration and recommend policy and procedural changes to improve operations to the division’s PR Team Leader prior to implementation.
  • Serve as the primary PR Team reviewer of protocol registration-related reports and documents from contractors (SOPs, quarterly and annual progress reports, timelines, procedure changes, etc.).
  • Coordinate and provide project management for the continued development of the division’s Protocol Registration System (DPRS) module in the division’s ES.
  • Provide guidance, consultation and expert advice on regulations, policies and procedures to division staff and researchers and to domestic and international research organizations involved in division-sponsored research.
  • Analyze and interpret regulations, policies and procedures and provide oral and written explanations and recommendations.
  • Establish quality assurance standards and metrics for PR policies and procedures.
  • Coordinate and communicate with other division, institute, and NIH counterparts to ensure consistency and harmonization of regulatory procedures and strategies.
  • Advise the PR Team Leader and division leadership on compliance with regulations, policies and procedures related to protocol registration.

 

Requirements
  • Master’s degree in a related field is required.
  • Minimum of three (3) years of experience in clinical research operations.
  • Strong organizational and communication skills, both oral and written.
  • Proficient in MS Office including Word, Excel, Outlook, and PowerPoint.

 

 

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.