REDCap Specialist / Clinical Scientist

Description

Position Title: REDCap Specialist / Clinical Scientist

Reporting to: Associate Director, Clinical Development

Location: San Diego, CA 92121

Employment: Full-Time

Salary range: $90,000 - $110,000

(Compensation may vary based on related skills, experience, and relevant key attributes)

n-Lorem Foundation:

Though n-Lorem is pioneering a novel non-profit model, to provide personalized experimental ASO treatments for free, for life to patients with the rarest of mutations (nano-rare), we are functionally a biotechnology company. We have a large and growing portfolio of ASO medicine discovery programs, ASO medicines in development and multiple clinical programs.

With a seasoned leadership team and strategic partnerships, the n-Lorem Foundation provides the framework, funds and access for nano-rare patients who are amenable to our technology to receive personalized ASO medicines for free, for life. We hope that you will consider joining us as we strive to change the world, one nano-rare patient at a time.

If you are a professional with strong REDCap experience and would like to join a cohesive, experienced team committed to the belief that we can change the world one patient, one family at a time, we may have a position for you.

Job Overview:

Reporting to the Associate Director, Clinical Development, the REDCap Specialist / Clinical Scientist will support n-Lorem’s Clinical Development team. The primary responsibility of this position will initially be the design, development, testing, and maintenance of electronic data capture (EDC) instruments and clinical databases in REDCap.

The ideal candidate will also have a foundational understanding of clinical research and clinical development from a Clinical Research Coordinator (CRC) perspective, including study protocols, clinical data collection, site interactions, data queries, and clinical study operations. As our clinical development portfolio grows, the individual will have the opportunity to support a range of clinical operations and data management activities beyond REDCap.

This position is well suited for someone with 2-4 years of clinical research experience who has hands-on REDCap experience and is interested in developing broader experience across clinical development, clinical operations, and clinical data management.

Key Responsibilities:

REDCap and Clinical Data Management:

• Build and configure REDCap projects, instruments, surveys, and databases based on study protocols, data collection requirements, and clinical development needs.
• Set up branching logic, calculated fields, validation rules, alerts, and other REDCap functionality to support accurate and efficient data collection.
• Develop and maintain longitudinal REDCap projects throughout the clinical study lifecycle.
• Perform quality control testing of REDCap builds prior to project go-live and following database updates.
• Troubleshoot REDCap issues and implement database modifications as study requirements evolve.
• Maintain documentation related to REDCap builds, testing, database specifications, and approvals.
• Support data cleaning activities and identify, investigate, and resolve data discrepancies.
• Generate and manage data queries in collaboration with Clinical Development team and study sites, as appropriate.
• Support data exports and preparation of clinical data for review and analysis.

Clinical Research and Clinical Operations Support:

• Apply an understanding of clinical research and clinical development workflows to ensure REDCap databases appropriately capture protocol-required data.
• Collaborate with Clinical Development team, study coordinators, and investigators to translate clinical requirements into functional data collection tools.
• Support review of study protocols, data collection requirements, and clinical documentation to inform database development.
• Assist with clinical operations activities as needed, including study start-up, site communications, study tracking, and ongoing study management.
• Support Site Initiation Visits (SIVs), data review, study documentation, and other clinical operations activities as needed.
• Perform site training on REDCap database.
• Participate in cross-functional clinical development activities and take on additional responsibilities as the organization's needs evolve.
• Maintain flexibility to support both data management and clinical operations activities based on workload and organizational priorities.

Requirements

Key Requirements:

• U.S. work authorization without the need for current or future sponsorship.
• Bachelor's degree in health-related, life sciences, clinical research, data, or other relevant field.
• 2-4 years of professional experience in clinical research, clinical operations, clinical data management, or a related field.
• Demonstrated, hands-on experience building and maintaining projects in REDCap.
• Demonstrated ability to interpret complex clinical trial protocols and translate to case report forms and/or electronic case report forms.
• Understanding of clinical research and clinical operations processes from a Clinical Research Coordinator (CRC) perspective.
• Familiarity with clinical research terminology, study protocols, data collection requirements, and clinical study workflows.
• Familiarity with REDCap features including branching logic, calculated fields, validation rules, longitudinal projects, and data exports.
• Strong attention to detail and commitment to data quality.
• Strong organizational, problem-solving, and communication skills.
• Ability to work independently while collaborating effectively with a multidisciplinary clinical development team.
• Ability to adapt to changing priorities and take on responsibilities beyond the primary REDCap role as needed.
• High proficiency in Microsoft Office, including Word, Excel, Outlook, and PowerPoint.

Preferred Qualifications:

• Experience supporting multiple clinical studies or research programs.
• Familiarity with IRB requirements, informed consent processes, HIPAA, and Good Clinical Practice (GCP).
• Experience with longitudinal clinical research databases.
• Experience developing data dictionaries, database specifications, or other data management documentation.
• Experience supporting clinical study start-up, site initiation, monitoring, or other clinical operations activities.

n-Lorem offers a competitive benefits package including medical, dental, vision, 403(b), 4 weeks paid vacation, paid sick time, life insurance, employee assistance program. n-Lorem is a small foundation with an extraordinary mission, to provide hope and potentially help to nano-rare patients today. Every employee in our organization is a significant contributor to this mission. We know that our work could have a profound impact on the life of a patient today.

n-Lorem is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. n-Lorem is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know.

For more information on n-Lorem, please visit our website www.nlorem.org