Clinical Data Associate

Location
Bethesda, MD, US
Posted
Feb 11, 2021
Ref
2020-4368
Discipline
Clinical, Clinical Data
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time
Overview

Medical Science & Computing (MSC), a Dovel company, is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

Duties & Responsibilities

MSC is 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 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

Requirements
  • 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.
  • Good communication skills.


Medical Science & Computing (MSC), a Dovel company, is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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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 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.