Job Description
Job Description
About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
Care Access Research is currently looking to hire a full time, remote, Source Document Specialist. The Source Document Specialist will be responsible for creating, maintaining, and controlling accurate versions of source documents (eSource or paper) for each clinical trial to substantiate trial activities.
How You'll Make An Impact
- All source documents will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to Care Access Research internal SOP.
- Initial creation of e-Source with use of all available protocol specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided templates/worksheets, or reference manuals) to design source documents that are accurate and complete and to ensure that the source document is equipped to record all the required data for a clinical trial.
- Create paper source templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments.
- Review draft source and ensure it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial.
- Coordinate initial source review and update process.
- Maintain version control of all source documents.
- Update current source as needed per protocol amendments.
- File, maintain, distribute, organize, and archive source for each clinical trial
- Manage daily communication with Site staff and other internal departments
The Expertise Required
- Experience as a Clinical Research Coordinator with diverse and complex clinical trials preferred.
- Skilled and proficient with e-Source build and design (e.g. CRIO/Clinical Conductor)
- Skilled in creation and revision of paper source templates.
- Ability to interpret clinical trial protocol and determine how to design complete and accurate source documents.
- Self-motivated, task oriented, detailed person who can work independently prioritizing responsibilities and adhering to project deadlines.
- Ability to create source documents in Excel.
- Willing to learn computerized programs used in creating eSource.
- Good verbal and written communication skills, especially for the remote work environment, including editing, proofreading, and grammar skills.
- Highly organized.
- IT Skills including Word, Email and Direct Messaging, digital document maintenance, and expert level in Excel.
- Ability to work well within a team.
Certifications/Licenses, Education, and Experience:
- Bachelor's degree in a relevant field (Life Sciences, Healthcare, or related discipline), or relevant experience.
How We Work Together
- Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
- Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
Benefits & Perks
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com