Clinical Data Associate
Company: Medical Science
Posted on: May 31, 2021
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
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
- Work in a team environment to support eCRF design and end user
- 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
- 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
- Experience with Microsoft Excel for data reporting.
- Skills in prioritization, organization, and time
- Experience with clinical/medical terminology and abstracting
data from patient records.
- Good communication skills.
We are a trusted government partner that blends deep domain
expertise with advanced technologies to help our customers solve
complex problems that improve, protect, and save lives. As a
rapidly growing company, we combine entrepreneurial spirit,
customer focus, and an outcomes-based approach to support agency
missions in health IT, life sciences, public safety, and grants
The Dovel Family of Companies offers employees an opportunity to
advance beyond a specific role or contract, we offer a path to
develop an enriching career. We believe in empowering a culture of
innovation, customer success, and employee growth.
What you'll get
- Time Off! Flexible schedules and company paid holidays allow
you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to
keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options
like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs,
we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care
Flexible Spending, HSA with company contributions, parking, and/or
transit commuter benefits.
- Support! Working parents and busy professionals - we've got you
covered with a supportive culture, confidential Employee Assistance
Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs,
company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and
have your voice heard.
We are an Equal Opportunity Employer with a commitment to
diversity. All individuals, regardless of personal characteristics,
are encouraged to apply. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, gender, sexual orientation, gender identity, disability,
or veteran status.
Keywords: Medical Science, Bethesda , Clinical Data Associate, Other , Bethesda, Maryland
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