Source Job

• Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices.
• Independently leads EDC development, including CRF development, EDC specification process, edit check development and User Acceptance Testing.
• Effectively oversees contracted vendors to ensure data are complete, accurate and delivered within agreed on timelines.

Adverum Biotechnologies, Inc., a wholly owned subsidiary of Eli Lilly and Company, develops gene therapy as a new standard of care for ocular diseases. They are a clinical-stage company aiming to deliver therapies in physicians’ offices to eliminate the need for frequent ocular injections.

• Perform cancer casefinding, accessioning, and abstraction of oncology cases into VHA-approved cancer registry software.
• Complete the full NAACCR data set, including VA-specific supplemental fields, to produce a comprehensive patient record.
• Maintain patient follow-up information including last vital status, disease status and supporting documentation.

Aptive Resources supports Veterans Health Administration facilities and offices across the U.S. with health care staffing and program support. They are an award-winning company that share an agile, mission-focused, results driven approach in the federal sector.

• Works in partnership with the primary point of contact to provide high quality, accurate data management support for complex studies.
• Maintains a working knowledge of parallel processes that are integrated with the function of clinical trial data, and is responsible for the compilation, registration and submission of data.
• Supports the implementation of custom, research project-specific data workflow solutions for data collection, management, reporting and analytics.

The University of Rochester is committed to the ideal of “Ever Better” and the values we share: equity, leadership, integrity, openness, respect, and accountability. It is one of the world’s leading research universities.

• Responsible for case finding, data abstraction and follow-up of patients with a diagnosis of cancer.
• Performs clinical data abstraction by capturing the complete patient history, diagnosis, staging and treatment information.
• Performs quality assurance activities when assigned such as review of abstracted data for accuracy, peer reviews, resolution of data edits.

Emory University is a leading research university that welcomes candidates who can contribute to the excellence of its academic community. Winship Cancer Institute is Georgia’s only National Cancer Institute-designated Comprehensive Cancer Center dedicated to discovering cures for cancer and inspiring hope.

• Responsible for the collection and reporting of data regarding cancer identification, treatment, and follow-up on each eligible cancer patient.
• Participates in data quality activities such as peer audits, data edits, and special quality projects as assigned.
• Maintains the cancer registry database (s) and generates necessary reports to meet the needs of the cancer registry customers

UChicago Medicine, a world-class academic healthcare system is seeking a Tumor Registrar in the Cancer Registry department. They value passion, talent and commitment… with patients and with each other.

• Establishes and maintains a document management system for regulatory electronic files.
• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
• Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.

Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.

• Assist in reviewing new study creation, activation and post-activation processes for clinical research studies submitted to the CTMS.
• Enter financial study information in the CTMS per study contract and/or finalized study budget.
• Detailed review of new study creation and proposed changes, identify problematic areas and communicate directly with internal and external personnel.

The Clinical Research Services Office oversees industry-sponsored research contracting, clinical research billing compliance, OHSU's clinical trials management system, and federal reporting compliance. They also engage clinical research staff in community building, training, and education.

• Assist Clinical Project Manager in the development and management of company-sponsored global clinical trials.
• Provide support in site recruitment, site initiation, site payments and site close-out.
• Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.

ImmunityBio, Inc. is a commercial-stage biotechnology company that develops cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system. The company is publicly traded with headquarters in Southern California, offering a collaborative environment with professional development opportunities.

• Act as a central contact for Clinical Study Teams for TMF management and participate in the development of quality oversight processes for TMF management of clinical trials.
• Review and approve TMF documents, co-author and manage TMF documents such as TMF Plan and Index, and ensure quality management by reporting metrics and reconciling outstanding queries.
• Oversee the activities of external vendors, ensuring study documents are adherent with ICH-GCP guidelines and regulatory requirements and that assigned studies are inspection-ready.

Oruka Therapeutics develops novel biologics designed to set a new standard for the treatment of chronic skin diseases like plaque psoriasis. It is a growing biotech startup building its core team with an engaged, inclusive, and positive company culture focused on making a difference.

• Expertly lead the identification, collection, abstracting, coding, staging, and follow-up of cancer cases, rigorously ensuring data accuracy and regulatory compliance.
• Meticulously identify and confirm cancer diagnoses, applying in-depth knowledge of disease processes to accurately abstract and assign codes and stages using established systems.
• Maintain current guideline knowledge, enter data into the registry database, and ensure compliance with all state and federal standards and productivity metrics.

St. Joseph's Hospital and Medical Center is a not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895, St. Joseph's remains dedicated to its mission of caring for the poor and underserved and is a nationally recognized center for quality quaternary care, medical education and research.

• Hold a leadership role within the study team, overseeing and guiding clinical trial activities at a country or regional level.
• Ensure high-quality execution, compliance, and timely delivery while acting as a key coordination point across cross-functional teams.
• Focus on leadership, mentorship, and remote oversight of monitoring practices with minimal to no site assignments and a low-travel model.

PSI is a leading Contract Research Organization focusing on delivering quality and on-time clinical trial services across various therapeutic areas. With over 25 years in the industry, it offers a balance of stability and innovation, fostering a dynamic team environment.

• Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for over 35 trials per year.
• Serve as the internal project manager for assigned oncology disease groups, providing timely updates on submission status and regulatory guidance on study development.
• Act as the liaison between sponsors, investigators, Winship, Emory IRBs, external IRBs, and internal departments, ensuring all facets of each protocol are compliant.

Emory University is a leading research university that fosters excellence and attracts world-class talent. Winship Cancer Institute of Emory University is Georgia's only National Cancer Institute-designated Comprehensive Cancer Center dedicated to discovering cures for cancer and providing innovative therapies and clinical trials.

• Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III).
• Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs).
• Design and review statistical methodologies for efficacy and safety analyses.

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.