Clinical Data Associate

Location
Bethesda, Maryland
Posted
Jul 24, 2021
Ref
2021-10123
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

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.

 

Requirements

 

Required qualifications:

 

  • 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.

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Company Description

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 management.

 

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.