Source Document Manager

About Us:

Flourish Research is where clinical trials thrive. Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. 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 is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. 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! 

 Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.

 About the Job:  

We are actively hiring a remote Source Document Manager

Shift: Monday-Friday day shift
Location: Remote
FLSA Classification: Exempt
Compensation: $85k-$95k

ESSENTIAL JOB FUNCTIONS:

• Lead Flourish Research as a subject matter expert in source documentation management.
• Coordinate with HR to recruit and interview new regional Source Creation Specialists.
• Maintain the source creation SOP and process for the team and sites.
• Train Source Creation Specialists to build, review, and maintain study source.
• Create tools and provide guidance to track and manage workload.
• Drive implementation of the eSource system at newly acquired sites.
• Attend and participate in site integration meetings to provide status updates and follow-up on action items.
• Track and report on site integration metrics and proactively identify potential roadblocks.
• Train site staff and investigators to update study source and enter data.
• Create training materials and tools to ensure consistency. Maintain training library.
• Manage regional Source Creation Specialists to ensure consistency in processes across sites.
• Schedule and host regular team meetings and 1:1s to foster a healthy team culture.
• Build and create study source documents compliant with Flourish SOPs, when necessary, to support regional Source Creation Specialists.
• Troubleshoot solutions with site management, site staff, and Source Creation Specialists when issues are identified.
• Escalate major or critical issues to site management and leadership.
• Liaise with vendor support staff to resolve issues and provide feedback, offer opportunities for improvement.
• Create chart/grafts/slides to use in quarterly updates to leadership on site progress. Present the materials as needed.
• Maintain an open line of communication on daily with team and department leadership.
• Maintain confidentiality of sponsor and Flourish trade secrets.
• Create error free written documents and reports (e.g. cover letters, notes-to-file, memos, etc.).
• Perform all duties in a time- and cost-effective manner.
• Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors.
• Additional duties assigned by Management

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

• Work is normally performed remotely.
• Travel required up to 50%.
• Vendor Customer Service.
• Daily computer usage.
• Occasional night and weekend work schedules.
• Ability to properly lift up to 25 pounds and occasionally more than 25 pounds.
• Ability to drive, and daily availability of an automobile.

MINIMUM REQUIREMENTS:

• Bachelor’s degree or commensurate experience.

Experience:

• Minimum of 5 years’ experience in clinical research industry. Minimum of 3 years’ experience in building study source documents.

Knowledge and Skills:

• Must have extensive eSource system experience (RealTime eSOURCE preferred).
• Consistently demonstrates core values & high proficiency of skills set.
• Must be experienced with Microsoft office applications (Outlook, Word, and Excel) as well as internet-based applications.
• Must be detail oriented, organized, self-motivated, be able to work independently and on a team, and the ability to stay on task.
• Must be able to manage and effectively prioritize a high-volume workload.
• Must possess excellent interpersonal skills including written and verbal communications.
• Is moral and ethical in decision-making and during interaction with investigators and site staff.
• Must be professional and have a strong work ethic.
• Must have the ability to adapt and take on additional tasks as requested.
• Ability to problem solve while working closely across departments.
• Develops and implements key initiatives in the department.
• Identifies and implements process improvements for increased efficiencies.
• Builds and fosters relationships across teams

Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays. 

Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.