The Role
What We Do
Care Access is a unique, multi-specialty network of research sites that operates as one connected team of physician investigators, nurse coordinators, and operations managers.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
Care Access 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.
What You'll Be Working On (Duties include but are not limited to):
- All source documents will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to Care Access 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
Physical and Travel Requirements:
- Remote role, with minimal travel requirements
What You Bring (Knowledge, Skills, and Abilities):
- 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.
Benefits:
- PTO/vacation days, sick days, holidays.
- 100% paid medical, dental, and vision Insurance. 75% for dependents.
- HSA plan
- Short-term disability, long-term disability, and life insurance.
- Culture of growth and equality
- 401k retirement plan
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to 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 value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
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The Company
What We Do
Care Access is a leading decentralized research organization (DRO) that breaks down traditional barriers in clinical research for patients, sponsors, and physicians. Its innovative model brings decentralized trials, Sites On Demand™, Virtual PIs, and Mobile Sites to previously-unreachable patient populations to expand the impact of clinical research. Supported by top pharmaceutical and biotech partners across 20 different therapeutic areas, Care Access is scaling and globalizing its new model for clinical trial delivery, where more physicians and patients can engage in life-saving research to develop new therapies faster.
To find out how Care Access is transforming the future of clinical trials, visit www.careaccess.com or email [email protected].
