Clinical Data Associate
MSC is currently searching for a Clinical Data Associate to support the National Institutes of Health (NIH). This opportunity is full-time, and it is on-site in Bethesda, MD.
The Clinical Data Associate provides subject matter expertise for clinical data management on NIH clinical trials. The Clinical Data Associate oversees data management of multiple complex studies, completes data entry and abstraction, conducts data quality control, and serves as an internal data management expert.
Duties & Responsibilities
- Adhere to NIH Clinical Data Management project timelines on multiple complex protocols.
- Support data abstraction from patient records and data entry of assigned studies, gather and enter data in accordance with SOPs and protocol specific processes.
- Ensure adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining data integrity and quality throughout a clinical study.
- Work in a team environment to support eCRF design and end user testing.
- Develop protocol specific data management plans ensuring alignment with protocol and data quality standards.
- Conduct data quality checks and data reviews.
- Provide data management support in preparation for and response to continuing reviews, monitoring visits, data safety monitoring board (DSMB) meetings, and audits.
- Participate in cross-functional process initiatives and clinical research team meetings.
- Abstract and grade adverse events based on the protocol specifications and SOPs.
- Other duties as assigned.
- Bachelor’s degree in Life Science or related field.
- One to two years’ experience in data management.
- Knowledge of Federal information technology, the Biotech or Pharmaceutical Industry, or equivalent comparable background.
- Experience with clinical trial databases and electronic data capture (EDC).
- Experience with GCP and Human Research Subjects Protection guidelines, as well as regulatory requirements relating to clinical development and compliance with safety, ethical, legal, and regulatory standards.
- Experience with Microsoft Excel for data reporting.
- Skills in prioritization, organization, and time management.
- Experience with clinical/medical terminology and abstracting data from patient records.
- Good communication skills.
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.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.
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