Source Creation Specialist (32551)

POSITION SUMMARY:

The Source Creation Specialist ensures accuracy and quality of research data by supporting quality control. The role has a specific responsibility for designing, developing, and maintaining study-specific source documents to ensure accuracy, regulatory compliance, and alignment with study protocols. This role is critical in supporting data integrity and inspection readiness.

ESSENTIAL JOB RESPONSIBLITIES:

• Review study protocols and creates compliant source documents tailored to each protocol for all research trials in each company market.
• Collaborate with study teams, investigators, and coordinators to ensure usability of source forms.
• Ensure that all source documents meet sponsor, IRB, and regulatory requirements.
• Update and revise source templates based on protocol amendments or feedback.
• Maintain version control and archiving of all source documents.
• Train site staff on correct use of source documents to ensure accurate data capture.
• Support audits and inspections by providing well-documented, compliant source materials.
• Collaborate with finance to ensure all invoiceable are correctly tied to source within the CTMS system.
• Participate in study kick off calls to communicate source development efforts and train site staff on source specifics.
• Collaborate with site staff and site managers to ensure protocol updates and all up to date eCRF guidelines are available for use in a timely manner.
• Proactively roll out source post protocol amendment and ensure site staff is aware of source updates.
• Work alongside finance to review and/or create budget templates within the CTMS system to support source creation.
• Follows up with staff to resolve internal data queries within the CTMS as needed.
• Updates source documents as updates to protocols occur and errors are found.
• Support with analyzing quality data to determine areas of growth and improvement.
• Supports strategy to improve quality across all markets.
• Facilitates ongoing trainings and shadows visits as needed for eSource use and quality improvement.
• Other duties as assigned

ROLE QUALIFICATIONS: (experience, education, and skills)

• Bachelor's degree in life sciences, healthcare, or related field.
• 2-4 years of experience in clinical research, including source document creation.
• Strong knowledge of GCP, FDA, and ICH requirements.
• Excellent attention to detail and document management skills.
• Complex specialty therapeutic area trial experience preferred. Ex: Urology, Neurology, Endocrinology, etc.
• Ability to collaborate across multiple teams and stakeholders.
• Understanding of clinical trial budgets and how they relate to source documentation creation in a CTMS system.
• Exceptional time management skills and the ability to prioritize varying trial recruitment timelines.
• Excellent communication skills and the ability to interact with all levels of management, staff, vendors, sponsors, and providers.

PERFORMANCE REQUIREMENTS:

Knowledge

• Knowledge of clinical research in a specialty setting; clinical research software, and sponsor requirements for source documentation creation.
• Understanding of medical terminology and a large array of medical procedures/processes relatable to clinical research.

Skills

• Ability to use relevant computer and software systems.
• Interpersonal and communication both with internal staff and external customers.
• Skill in evaluating and implementing source creation plans
• Time Management.

Abilities

• Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
• Elicit appropriate information for source creation to site staff.
• Ability to read and understand information and ideas presented in writing.
• Ability to apply general rules to specific problems to produce answers that make sense - deductive reasoning.

REPORTING TO THIS POSITION: None

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions:

• Physical demands: Involves sitting approximately 70-90 percent of the day, walking or standing for the remainder.
• Work environment: 100 % Remote setting.