Clinical Research Source Development Coordinator

🔥 0 minutes ago

🏈 Alabama, Arizona, +9 more states – Remote

🏈 Alabama – Remote 🌵 Arizona – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🎰 Nevada – Remote 🍂 Massachusetts – Remote 🚗 Michigan – Remote 🏰 Missouri – Remote 🌴 South Carolina – Remote 🤠 Texas – Remote ⚔️ Virginia – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

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Alcanza Clinical Research

WebsiteLinkedInAll Job Openings

201 - 500 employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🔬 Science

Healthcare Insurance • Biotechnology • Science

Alcanza Clinical Research is a company dedicated to advancing clinical research through inclusive and impactful methodologies. They facilitate the participation of diverse populations in clinical trials by lowering barriers and ensuring high-quality research practices. Alcanza collaborates with medical providers and community organizations to provide patients with access to cutting-edge treatment options and health education across various therapeutic areas, without requiring insurance. Participants can benefit by receiving healthcare access, emerging treatments, and compensation for their time. The company is committed to patient safety and data integrity, providing opportunities for individuals to contribute to healthcare advancements across many locations in the United States.

📋 Description

• In collaboration with other members of the clinical research site team, works to support source document requirements for assigned studies. • Creation of source documents that will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to internal SOPs. • Create templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments. • Initial creation of source documents will use all available protocol specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided source templates/worksheets, or reference manuals) to create a source document that is accurate and complete and to ensure that the source document is equipped to record all the required data for the visit. • Creating, maintaining, updating, control, and release source documents, including paper and electronic source documents in line with the study protocol, and relevant sponsor guiding documents. • Reviewing draft source and ensuring it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial. • Coordinating initial source review and update process. • Filing, maintaining, distributing, organizing, and archiving source documents for each clinical trial. • Updating current source documents according to new clinical study protocol amendments. • Activating studies and visits at the appropriate time. • Supporting Quality Control (QC) of source documents before it goes to the users. • Attending all relevant meetings to stay up to date with upcoming studies, progress on current studies, and studies closing out. • Maintaining a single tracker for the department to track source document design activities and the status of the activities. • Maintaining version control of all source documents. • Managing daily communication with site staff and other internal departments. • Remaining up to date with all assigned Clinical Study Protocol for study. • Developing and maintaining excellent working relationships with internal and external clients to understand and meet their needs in line with company policies and procedures. • Maintaining a positive, results-oriented work environment, building partnerships within the team and across the organization at large, and modeling teamwork. • Participating in continuing education activities to maintain current knowledge of source document design and relevant software. • Performing all other duties that may be requested or assigned.

🎯 Requirements

• An Associate’s degree in technology, biological science, business, or related field, AND 1+ years of clinical research experience, OR an equivalent combination of education and experience is required. • Strong knowledge of clinical trials and designing source documents (paper and electronic) is highly preferred. • Experience as a CRC with diverse and complex clinical trials preferred. • Proficiency with computer applications such as Microsoft applications, email, electronic health records, and web applications and the ability to type proficiently (40+ wpm). • Strong organizational skills, attention to detail, and math proficiency. • Well-developed written and verbal communication skills. • Well-developed interpersonal and listening skills and the ability to work independently as well as with co-workers, subjects, managers, and external customers. • Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities. • Ability to be professional, respectful of others, self-motivated, and exemplify a strong work ethic. • A high degree of integrity and dependability. • Ability to work under minimal supervision, identify problems and implement solutions. • Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.

🏖️ Benefits

• Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. • Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.