Clinical Research Coordinator
We are currently searching for a Clinical Research Coordinate to provide support to the National Institutes of Health (NIH). This opportunity is a part-time position with MSC and it is on-site in Rockville, MD.
Duties & Responsibilities
- Devise working plans and standards of practice for the identification, screening, randomization and enrollment of subjects in IRB approved clinical trial protocols at sponsored international sites in collaboration with local investigators.
- Oversee the implementation all trial related activities according to each individual IRB approved clinical trial protocol, established Standard Operating Procedures (SOPs), sponsor specifications and Good Clinical Practice (GCP).
- Build and maintain excellent communication with Principal Investigators and collaborators at international sites in order to conduct high quality clinical trials.
- Ensure efficient monitoring of all trials by ensuring that the data is clean and entered accurately into the sponsor EDC in a timely fashion.
- Coordinate with international colleagues site initiation activities as well as oversee the set-up and maintenance of studies.
- Create and submit regulatory and associated documents as needed to start new clinical trials.
- Maintain both new and ongoing IRB processes.
- Revise IRB submissions in response to identified problems and resolve issues in a timely manner.
- Review audit findings from the medical monitor and/or internal auditor and discuss with Principal Investigators when needed.
- Prepare reports summarizing clinical and research information obtained for the purpose of communication with the IRB and publication.
- Interface with clinical laboratories, contract laboratories, NIH research laboratory personnel and outside laboratories to ensure correct and timely specimen collection and track results of testing.
- Track and obtain knowledge to observe and report adverse/serious adverse events, protocol violations/deviations in a timely and accurate manner in collaboration with international colleagues
- Attend all clinical operations meetings and conduct strategic planning as needed.
- RN, PA, NP Degree or equivalent preferred.
- Prior experience working as clinical study coordinator required.
- French language skills desirable but not required.
- Must be able/willing to travel to study sites in Mali (2-3) times per year for approximately (5-7) days per trip.
- Must be able to work a part-time schedule (30hrs/week).
Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.
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.
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