United States onlyWe are actively hiring a Source Creation Specialist!
The Source Creation Specialist will create and maintain source documents and facilitate review, ensuring compliance standards, Flourish’s SOPs, applicable federal regulations/ICH Guidelines, Good Clinical Practices (GCPs), and each sponsor’s and institutional review board’s (IRB) specific requirements.
Shift: Monday-Friday, 8 AM - 4:30 PM
Location: Remote
Compensation: $60,000 - $65,000/yr ($28.84 - $31.25/hr)
Classification: Hourly, Non-Exempt
Benefits: Health, dental, and vision insurance plans, 401(k) with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays.
RESPONSIBILITIES
- Adhere to the established SOP and instructions when performing quality control review of completed source documents.
- Knowledge of all awarded protocols and applicable supporting manuals to create source documents
- Participate in study-related meetings, including but not limited to study award meetings, planning meetings, screening trainings, protocol trainings, and SIVs.
- Read and understand each assigned protocol.
- Build source document study design specifications.
- Design and maintain source documents in compliance with Flourish's safety and emergency policies and procedures.
- Manage source document review from End Users.
- Escalate any protocol discrepancies noted or lack of protocol clarity to the Process Quality Director and sponsor resolution before finalizing source document.
- Address all End User findings and make changes as applicable
- Track general findings from source review for future improvement.
- Format all paper source document pages for final printing.
- May activate all eSOURCE based on End User approval.
- Maintain an open line of communication on a daily and weekly basis with the team and other department members.
- Escalate any critical or major findings or trends from all quality control review to the Process Quality Director
- Abide by all HIPAA regulations.
- Maintain the confidentiality of the sponsor and Flourish trade secrets.
- Create error free written documents and reports (e.g. cover letters, notes-to-file, memos, etc.).
- Perform other tasks as assigned by leadership.
- Bachelor’s degree or equivalent experience
- Minimum 2 years’ experience in the clinical research industry
- Proficient with Microsoft Office (Outlook, Word, Excel) and web-based applications
- Highly detail-oriented, organized, and self-motivated
- Able to work independently and collaboratively within a team
- Excellent written and verbal communication skills
- Demonstrates strong critical thinking, problem-solving, and sound judgment
- Professional, ethical, and patient-focused in all interactions (patients, sponsors, IRB, physicians, staff)
- Adaptable and willing to take on additional responsibilities as needed
- Drives and supports departmental initiatives and process improvements
- Builds and maintains effective cross-functional relationships
Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!
Flourish Research is where clinical trials thrive.
Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.
At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.
Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.
Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!
It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
