Clinical Research Specialist Solution Expert

Edera L3C is a fast-growing healthcare consultancy that addresses today's issues and helps create tomorrow's solutions by connecting the brightest minds in healthcare. Our team of management, technology, and creative services consultants work collaboratively with industry experts who bring deep experience and expertise to create transformational business solutions. We believe complex challenges and multi-faceted opportunities call for multi-disciplinary approaches and that's how we work. We transform healthcare by bringing industry best practices from the private sector to the public sector, and the public sector to the private sector. Edera is an L3C (a variation of a limited liability company) that places "purpose before profit;" a social enterprise venture. This means we are focused on a socially beneficial mission to transform organizations rather than being driven to maximize income. Profits beyond our business sustainability goals are reinvested into communities or clients.

We are seeking a Clinical Research Specialist (CRS) to join our dynamic and mission-driven clinical research team. The Clinical Research Specialist will support multiple ongoing and upcoming clinical research studies, ensuring seamless coordination of daily operations, regulatory compliance, and strict adherence to protocol requirements.

This role plays a pivotal part in advancing health equity through inclusive and accessible research. The CRS will contribute to leading innovative clinical trials by refining program workflows and enhancing the participant experience across all touchpoints - including registrants, vendors, and key stakeholders.

The ideal candidate will bring extensive experience working with Cerner electronic health records (EHR) and within Department of Defense (DoD) and/or Veterans Affairs (VA) healthcare environments. They will serve as a subject matter expert (SME) capable of bridging the gap between vendor technologies and clinical operations. This includes a strong understanding of system functionality, performance validation, and troubleshooting techniques. The CRS will be expected to evaluate existing workflows, identify areas of optimization, and recommend improvements to system design or operational processes.

Success in this role requires strong organizational skills, meticulous attention to detail, and a compassionate, participant-centered approach. The ideal candidate is also proactive, collaborative, and comfortable navigating complex technical and clinical environments.

APPLICANTS MUST HAVE VA AND/OR DOD EXPERIENCE - Active federal clearance or ability to obtain

Type of Employment: Full-time salaried and fully benefited position

Work Location/Travel: Expected 50% travel required; applicants must be free from travel restrictions to accommodate evolving needs of the client.

Salary Range: $80,000.00 - $106,500 base salary, depending on experience and location. Competitive salary/pay, potential for bonuses. There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position is highly competitive but dependent upon employment type (1099, contract, W2).

Role Reports to: Managing Director

Direct Reports: This role has no direct reports.

• Manage day-to-day operations of VA/DoD clinical research studies from initiation through closeout, ensuring compliance with GCP, IRB, and institutional policies.
• Coordinate participant recruitment, screening, consent, enrollment, and protocol-defined visits using Cerner EHR workflows.
• Maintain accurate documentation in Cerner, EDC systems, and regulatory logs; ensure data integrity and resolve sponsor queries.
• Support adverse event reporting, investigational product tracking, and biospecimen collection per protocol and SOPs.
• Collaborate with investigators, sponsors, CROs, and site monitors; facilitate site visits, audits, and regulatory submissions.
• Train and supervise junior research staff; ensure adherence to study procedures and VA/DoD standards.
• Develop study tools, support budgeting and invoicing, and monitor study progress against milestones.
• Communicate with pharmacy, lab, radiology, and informatics teams to coordinate study-related activities.

• Strong knowledge of FDA, ICH-GCP, HIPAA, VA Handbook 1200.05, and IRB regulations governing human subjects research.
• Proficient in interpreting clinical research protocols, informed consent, and documenting deviations or adverse events.
• Hands-on experience with Cerner Millennium, EDC systems (e.g., REDCap, Rave), and VA/DoD tools like CPRS or MHS GENESIS.
• Advanced user of Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and clinical trial management tools; experience with scheduling platforms, ePROs, and regulatory tracking software.
• Excellent communication, collaboration, and stakeholder engagement abilities.
• Detail-oriented with strong organizational skills, able to manage multiple trials and ensure protocol compliance.
• Proactive in identifying and addressing issues related to protocol adherence, safety, and data quality.
• Experience mentoring junior staff and supporting continuous improvement in research and EHR workflows.

• Bachelor's degree in Life Sciences, Healthcare, Public Nursing, Nursing or related field (or equivalent work experience).
• Clinical research certification preferred (e.g., CCRC, CCRP, or ACRP equivalent) is a plus (or relevant Cerner training).

Preferred - Education/Certification:

• Master's degree in Life Sciences, Healthcare, Nursing or Information Systems (preferred)

• 5+ years of proven success in supporting Clinical research including supporting Cerner EHR implementations.
• Experience working on multi-site or national studies.
• Expertise in regulatory submissions and IRB processes.
• Experience working with NIH, CMS, or FDA-sponsored studies is highly desirable.

• Proficient in Cerner Millennium (PowerTrials, PowerChart, PowerForms, MPages) with experience supporting clinical research workflows within VA/DoD environments.
• Skilled in data entry, query resolution, and monitoring within EDC platforms such as Medidata Rave, REDCap, Oracle Clinical, and Open Clinica.
• Familiar with eRegulatory systems including Florence eBinders, Veeva Vault, or VA-specific regulatory management tools.
• Advanced proficiency in Microsoft Office Suite- Word (documentation preparation), Excel (data tracking, pivot tables), PowerPoint (presentations), and Outlook (calendar management, communication).
• Comfortable using scheduling software, workflow tools, and study tracking systems to manage research operations efficiently.
• Experienced with systems supporting compliance with 21 CFR Part 11, HIPAA, and VA/DoD security protocols.
• Proficient in Microsoft Teams, SharePoint, and secure file-sharing platforms commonly used across federal healthcare settings.

All applicants must be US citizens and able to obtain a Public Trust clearance. Edera participates in the E-Verify program. Edera is a drug-free workplace.

Edera is an Equal Opportunity and Affirmative Action Employer. Edera prohibits discrimination against individuals based on their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other category protected by law.