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REDCap Clinical Data Engineer

3 months ago

Rockville, United States Covalent Solutions, LLC Full time

JOB SUMMARY

Covalent Solutions (Covalent) is seeking a mission driven, highly motivated and collaborative REDCap (Remote Data Capture - ) Clinical Data Engineer who is truly excited about building great products to support one of our clients at the National Institutes of Health (NIH). As a REDCap Clinical Data Engineer, you will oversee the end-to-end delivery of data management and data capture services for our customers’ clinical protocols. The REDCap Clinical Data Engineer will play a key role in project planning, execution, and protocol close-out, ensure adherence to Good Clinical Practices (GCPs), regulatory guidelines, SOPs, and other customer directed guidelines.


The REDCap Clinical Data Engineer will provide technical support as part of a team to develop and maintain clinical research databases.


This is a full-time position based in Rockville, Maryland.


DUTIES AND RESPONSIBILITIES include, but are not limited to:

  • Serve as the primary point of contact for customers on data management deliverables.
  • Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.
  • Maintain strong customer relationships.
  • Ensure open communications with customers
  • Plan and coordinate database design, development, implementation, maintenance, and user support of clinical data management systems.
  • Program, test, and document databases in accordance with programming standards and validation procedures.
  • Understand and comply with GCP, SOPs, Regulatory requirements, and Good Clinical Data Management Practices.
  • Meet objectives as assigned and interact with the project team to organize timelines, responsibilities, and deliverables.
  • Work with study teams, sponsors and investigators as needed to develop and implement Case Report Forms (CRFs), electronic, mobile, or paper as required by the customer.
  • Develop and maintain good communications and working relationships with internal team members
  • Assist in developing and implementing new technologies.
  • May assist in testing and evaluating new upgrades to technologies.
  • Responsible for support in developing/reviewing Case Report Forms (CRFs)
  • Work in the development of Standard Operating Procedures (SOPs) and Best Practice Guidelines
  • May be responsible for training customer data management and other team members.
  • May be responsible for presentation on various data management related topics at conferences (this includes live presentation, conference calls, web conference meetings as well as posters presentations).


QUALIFICATIONS

Education

  • Bachelor’s or master’s in computer science, biomedical science, or STEAM discipline
  • Professional certifications in clinical research such as those offered by the Society of Clinical Research Associates (SOCRA) and the Society for Clinical Data Management (SCDM).

Work Experience

  • 5+ years’ experience working with REDCap™.
  • Building and designing data entry forms (eCRFs) using REDCap's interface.
  • Configuring project settings, user roles, and permissions.
  • Creating and managing studies and surveys.
  • Generating reports and data exports in various formats (e.g., CSV, Excel).
  • Familiarity with REDCap API for data integration and automation.
  • Must be legal to work in the United States.
  • Prepared to undergo a US Government background check for public trust.
  • Fluent and literate in English with demonstrated capacity to communicate using standard office applications such as email, word processing, spreadsheets, and presentations.
  • Familiarity with FDA 21 CFR Part 11, GCP, SOPs, Regulatory requirements, SCDM Good Clinical Data Management Practices and FDA Computer Systems Validation/Assurance.


COMPETENCIES

Professionalism:

  • Sharp eye for detail.
  • Proven ability to manage multiple tasks concurrently and in different phases of work at the same time. Flexibility and adaptability to perform in a fast paced and dynamic environment. Context-switching does not bother you.
  • Effectively collaborates and influences people at all levels in the organization through strong interpersonal and communication skills.
  • Highly organized with strong time-management skills.
  • Ability to manage conflict and drive resolution.
  • Focused on results, proactive, service oriented
  • Can focus on both high level and detail level, knowing which is appropriate for the situation.
  • Ability to self-direct and manage ambiguity.
  • Ability to take in a lot of disparate information and find common themes, recommend clear paths forward and iterate.
  • Motivated by professional rather than personal concerns.
  • Show persistence when faced with difficult problems or challenges.
  • Naturally curious about things you don't understand and actively look for opportunities to grow and learn from those around you.

Communication:

  • Actively participate in meetings and be willing to advocate for what you believe in. Provide thoughtful, constructive review of others’ work, knowing that everyone is working towards the same objective.
  • Superior written and verbal communication skills. You can always articulate the "why" behind your solutions.
  • Listen to others, correctly interpret messages from others and respond appropriately.
  • Ask questions to clarify, and exhibit interest in having two-way communication.
  • Tailor language, tone, style and format to match the audience.
  • Demonstrate openness in sharing information and keeping people informed.
  • Speak intelligently about a wide variety of topics but know when to say, "I don't know."

Teamwork:

  • Work collaboratively with colleagues to achieve organizational goals.
  • Place team agenda before personal agenda.
  • Support and act in accordance with the final group decision, even when such decisions may not entirely reflect your own position.
  • Share credit for team accomplishments and accept joint responsibility for team shortcomings.

Accountability:

  • Take ownership of all responsibilities and honor commitments.
  • Deliver outputs for which you have responsibility within prescribed time, cost and quality standards.
  • Operate in compliance with organizational regulations and rules.
  • Take personal responsibility for your own shortcomings, where applicable.