The Clinical Trials Office provides diagnosis and management of benign and malignant tumors for inpatients and outpatients. The Cooperative Group Associate for the Clinical Trials Office will be a part of a National Cancer Institute-Designated Cancer Center that seeks to build synergies and collaborations across the University. The researchers are active in translational research with more than 400 cancer related clinical research studies ongoing at any time. The Cancer Clinical Trials Office is the centralized resource for managing these trials.
The Cooperative Group Associate will independently manage significant and key aspects of clinical research for the various cooperative groups in the Clinical Trials Office. Under the direction of the Quality Assurance Manager, the candidate is responsible for the following: tracking submission of long term follow up data, ensuring data compliance by monitoring and auditing of the Cooperative group studies at the Cancer Center and its affiliate sites, assure audit preparedness and readiness, and support Principal Investigators with data submissions, queries, and resolutions.
Reporting directly to the Quality Assurance Manager and indirectly to the Administrative Director along with the faculty leader of the cooperative group, the Cooperative Group Associate will advise staff that are conducting cooperative group clinical trials. The incumbent independently oversees and manages research protocols for cooperative groups. The Cooperative Group Associate will coordinate the clinical research efforts of the Moore's UCSD Cancer Center Clinical Trials Office. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials.
The incumbent's duties may include, but will not be limited to: acting as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; oversee study data integrity; implement and maintain periodic quality control procedures; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.
The Cooperative Group trials are conducted across twelve disease programs and include the following trial types 1) Alliance for Clinical Trials in Oncology which is sponsored by the National Cancer Institute (NCI); 2) NRG Oncology group which brings together the research areas of the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG); and, 3) SWOG, the South West Oncology Group.
Theoretical knowledge and or Bachelor's Degree in biology, microbiology, social sciences, public health, clinical or related field; and/or equivalent relevant work experience.
Proven knowledge and experience in managing cooperative group oncology clinical trials.
Demonstrated experience working with FDA policies regulating clinical trials.
Experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.
Experience performing clinical research duties in a clinical research environment. Administrative experience.
Demonstrated experience interpreting medical charts and abstracting data from electronic medical records.
Skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions. Experience coordinating study start-up activities.
Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.
Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as VELOS, Access, Excel and MS Word.
- Certification as a clinical research associate or coordinator or a Master's Degree.
- Knowledge of hematology/oncology.
- Ability to differentiate various cancers by stage, histology, and site to determine patient eligibility for protocols and ensure accurate randomization.
- Employment is subject to a criminal background check and pre-employment physical.
- Must be able to travel to different locations and work weekends and evenings as needed.
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