JOB SUMMARY
Covalent Solutions (Covalent) is seeking a mission driven, highly motivated and collaborative REDCap (Remote Data Capture - https://www.project-redcap.org/) Clinical Data Administrator 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 Administrator, you will oversee the end-to-end delivery of data management and data capture services for our customers’ clinical protocols. The REDCap Clinical Data Administrator 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 Administrator 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.