Clinical Research Coordinator
We are currently searching for a Clinical Research Coordinator to provide support services to satisfy the overall operational objectives of the National Institute on Alcohol Abuse and Alcoholism. The primary objective is to provide services and deliverables through performance of support services. This opportunity is full-time, and it is on site in Bethesda, MD.Duties & Responsibilities
- Coordinate with clinical staff to plan, prepare, implement, and monitor clinical research activities conducted by the laboratory, including subject accrual, monitoring of study data collection and entry into research databases, development and maintenance and review of case report forms, in accordance with data management and quality assurance plans
- Provide expert guidance and assistance to clinical investigators in the writing, preparation, and submission of protocols to the Investigational Review Board IRB, including initial submission, continuing review, amendments, audits, and other administrative requirements
- Work with staff on the evaluation of participants, conduct structured and semi-structured scales and questionnaires and other assessments
- Collaborate with PIs to track and coordinate regulatory activities for the study protocols, during conception development, as well as in all actions of protocol lifecycle, including scientific review, IRB initial and continuing reviews, IRB applications bioethics reviews, protocol amendments, study auditing activities, regulatory procedures involving the FDA, applicable Data and Safety Monitoring Board DSMB reviews, and study closures
- Maintain all clinical trial documentation including a complete and up-to-date regulatory binder for each trial, documentation of investigator qualifications, participant source documentation and case report forms, trial logs and safety reports
- Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB)
- Verify study participant information and collect data and results of testing
- Assist staff to develop, assemble related documentation, and maintain regulatory binders for all protocols
- Perform accurate and timely data analysis, report results and findings and respond to sponsor queries
- Assist researchers to develop, maintain and complete study data collection forms and source documents
- Assist staff to write and edit clinical research protocols and informed consent forms (ICFs) based upon templates
- Review draft protocols, case report forms, and manuals of operations for clarity, and completeness
- Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.
- Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events
- Provide continuity of care to patients enrolled on assigned protocols
- Assist key research personnel to ensure that clinical research activities are performed in accordance with federal, state, and institutional regulations, policies, and procedures
- Assist researchers to plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures
- Assist researchers to develop and maintain current and new research protocols
- Prepare and submit for review, accurate source documents related to all research procedures
- Research changes and updates to Good Clinical Practices (GCP) and prepare summaries, job aids and training materials for research staff and new clinical research coordinators
- Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging trends in clinical studies, new literature and findings and regulatory considerations
- Previous clinical trial work
- Protocol review & revision
- Patient confidentiality
- Preclinical experience
- Regulatory compliance
- Clinical Research
- MS Office Suite
- Bachelor’s Degree in General Medical and Health Services, Biology, Science, or Technology
- At least 1-2 years of specialized experience
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.