Clinical Protocol Coordinator

Location
Bethesda, Maryland
Posted
Jun 17, 2022
Ref
2022-12037
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time

We are currently searching for a Clinical Protocol Coordinator to independently provide support services to satisfy the overall operational objectives of the Division of Intramural Research, Stroke Branch, Stroke Diagnostics and Therapeutics Section at the National Institute of Neurological Disorders and Stroke.  This is a full-time, on-site opportunity in Bethesda, MD.  

Duties & Responsibilities
  • Assist researchers develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts.
  • Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids.
  • Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.
  • Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
  • Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.
  • Assist with the planning and execution of the most appropriate approaches to attain the laboratory’s research goals.
  • Develop or improve systems of data collection, verification, and management.
  • Evaluate and recommend new types of research approaches and recommend changes to processes/protocols, based on review and knowledge of the research priorities.
  • Measure project performance to identify areas for improvement.
  • Support the revision and development of human subject’s protocols as needed and assist with the coordination of activities and approvals.
  • Perform data collection validation and analysis, including regular internal audits of collected data at the research sites.
  • Recommend and assist with the implementation of improvements to work-flow and operational procedures to increase efficiency, productivity and make overall improvements for research activities.
  • Coordinate with PI and Senior Protocol Advisor to help coordinate research staff at multiple sits where research is conducted to assist with the planning, implementation and 3 monitoring of the clinical research protocols. Provide weekly to monthly progress reports on research projects.
  • Initiate and track research agreements and material transfer agreements (MTA) with all projects and researchers to define rights of the provider and recipient, in respect to data and its derivatives.
  • Work with staff on the training of personnel, research assistants, post-doctoral fellows, students, visiting scientists and others in specialized technologies.
  • Collaborate with staff on the preparation of internal research proposals, abstract submissions, poster presentations and manuscript drafts.
  • Assist researchers develop standard operating procedures (SOPs) for the clinical study.
  • Assist researchers prepare study reports and status updates, including amendments, audits, and other administrative documentation.
  • Assist researchers collect, organize, and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
  • Assist researchers prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
  • Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies.
  • Maintain data files within multiple software systems, including computerized procurement reports and communication programs.
  • Perform entry and cleanup of study of the questionnaire data in various databases and conduct queries to answer researcher questions.
  • Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals.
  • Assist researchers prepare, review, and submit clinical data to monitoring agencies.
  • Assist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval.
  • Assist researchers prepare submissions to regulatory bodies in support of clinical trials.
  • Assist staff on protocol coordination, including matching and locating control subjects, completing registration phone calls, reviewing study questionnaires, and resolving queries with patients.
  • Assist researchers coordinate recruitment, scheduling, travel, and admission of research study participants with clinical staff.
  • Assist researchers screen study participants and document results of screenings.
  • Liaison between study participants, participants’ relatives and staff members and communicate participants’ questions, complaints, problems, and concerns to appropriate staff members.

#SOAR

 

#LI-JR1

Requirements
  • Master’s degree in General Medical and Health Services
  • Minimum of one (1) year of experience in clinical research coordination or related field
  • Familiarity with IRB requirements
  • Clinical Trials
  • Previous clinical trial work
  • Experience in clinical data management databases operations and analysis
  • Liaising with regulatory authorities
  • Regulatory compliance
  • Protocol development
  • Clinical Research
  • Data Monitoring
  • SOPs
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.