Who are we?
Elixia is a trusted clinical site organization, providing industry-leading patient recruitment and clinical trials management and analysis for Cardiology/Nephrology, Behavioral Health, and Infectious Disease – not just for a single trial, but across your entire therapeutic pipeline.
Schedule:
- Full time
- Monday to Friday
- Weekends as needed
Summary: The Source Document Specialist performs, reviews, quality control and publishing of templated source documents that adhere to regulations and ensure consistency with collection of source data to achieve the technical quality while complying with protocol guidelines and requirements.
Responsibilities: The Source Documents Specialist:
- Receives, reviews, and processes incoming source documents;
- Ensures proper categorization and storage of documents
- Maintains document confidentiality and security;
- Reviews and understands protocol required elements as it relates to the collection of source data;
- Monitors source documents to ensure compliance with study protocols and with applicable federal, state, and local regulatory and site requirements and policies;
- Creates source documents on a per trial basis that aligns with all protocol required assessments, EDC required elements, while taking sponsor feedback into consideration in a timely manner;
- Reviews and modifies source documents based on participating sites’ feedback on the usability and accuracy of said source;
- Formats source documents in a sensible manner that aide in the completion of the study visits in a logical and sensible manner;
- Modifies existing, and approved source, based upon protocol amendments, and/or sponsor/site required edits;
- Submits all creations, amendments, and modifications to the Head of Quality Assurance Division for quality control review and document finalization prior to site use;
- Enters and updates data from source documents into database or other systems;
- Performs regular audits and quality checks to ensure compliance with internal standards and external regulations;
- Works closely with the Head of Quality Assurance Division, the Management team, and the Regulatory Department to submit finalized source;
- Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups;
- Follows Good Clinical Practice (GCP)
- Works cooperatively with others
- Maintains required records of source documents;
- Collaborates with Investigators and Company Management to prepare presentations or reports of source documents;
- Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research;
- Documents findings and events in the Company’s research CTMS platform and in other binders and platforms as directed;
- Occasional travel to Company sites, Investigator meetings, and/or Company meetings; and
- Performs other duties as assigned;
Qualifications
- Previous experience in document management, data entry, or a similar role
- Strong attention to detail and organizational skills
- Knowledge of regulatory requirements related to document management and data privacy
- Communication and interpersonal skills
- Previous clinical research experience
- Good Clinical Practice (GCP) Certification
Equal Opportunity: The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Retirement plan
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- Weekends as needed
License/Certification:
- Good Clinical Practice Certificate (Required)
- IATA Certification (Required)