- Develop and maintain expertise in the use of Clinical Research IO (CRIO) using available training tools and specialized instruction, particularly in source design.
- Understand the source data requirements of all assigned studies through reading protocols, attending relevant meetings, and coordinating with the medical, clinic, data, compliance, and finance teams.
- Perform Quality Control reviews on source documents created by other members of the Source Design Team, as assigned.
- Gather all required tools for the creation of source documents, including Electronic Data Capture (EDC) snapshots and guidelines, study protocol, study operations manuals, and other relevant documents that guide the collection of sponsor-required data points.
- Design initial source documents with lead oversight for all assigned studies prior to the Site Initiation Visit (SIV), to allow for clinical and financial review of source documents prior to their use.
- Attend all assigned SIVs and ensure that all questions affecting source documentation are adequately answered prior to the site being granted green light status.
- Maintain and update the tracking system to facilitate documentation of the creation and maintenance of all source documents, including dates, versions, and reviews by both clinical and financial parties.
- Update all assigned site source documents as required for all study protocol amendments prior to their next required use following the Institutional Review Board (IRB) approval of the amendment.
- Collaborate closely with the Source Manager to assist with the implementation of systems and procedures to continue to improve the source design process.
- Perform other duties as assigned or required.
- Strong knowledge of clinical research protocols and documentation requirements.
- Strong computer skills and an interest in learning to utilize new applications and functions.
- Exceptional critical thinking.
- Ability to determine and prioritize workload.
- Ability to handle multiple tasks/projects simultaneously.
- Exceptional communication skills, both verbal and written.
- Ability to collaborate with other team members to achieve results.
- Excellent organizational skills.
- Strong drive and personal initiative.
- Bachelor's degree required.
- At least 2 years of clinical research experience is required.
- Clinical Research Coordinating experience is preferred.
- Prolonged periods of sitting at a desk and working on a computer.
- Prolonged periods of standing, bending, and reaching.
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Source Designer - Orlando, United States - Charter Research
Description
COMPANY DESCRIPTION
Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is locally owned and prides itself on providing exceptional patient experience to our participants, as well as offering agile recruitment strategies to our sponsors. Above all, we are a team, and we are seeking the right team member to add to our foundation in Orlando.
POSITION OVERVIEW
The Source Designer is responsible for creating and maintaining source document templates for the collection of all study protocol related data. The person in this role will collaborate closely with the source manager, medical, clinic, data, compliance, and finance team members to create source documents that gather the data elements required by the sponsor, provide adequate documentation to support the site's compliance with all relevant regulatory requirements, and ensure proper invoicing and payments related to work completed.
RESPONSIBILITIES
KNOWLEDGE, SKILLS, AND ABILITIES
QUALIFICATIONS
Education
Experience
Applicants that don't meet 100% of the above qualifications but who have a combination of related education, applicable experience, demonstrated capability, and a genuine passion for success in this position may also be considered.
PHYSICAL REQUIREMENTS
Charter Research provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability status, genetic information, marital status, ancestry, protected veteran status, or any other characteristic protected by applicable federal, state, and local laws.
