Data Manager Therapeutic Interventional TI Sr Clinical Research Assistant | Oregon Health & Science University

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Department Overview: The mission of the Knight Clinical Research Management organization is to support the conduct of translational clinical research aimed at improving the lives of people and families with cancer by applying innovative strategies for cancer prevention, screening diagnosis and treatment. The support is proed through proactive, high quality and efficient study management inpliance with federal regulations and local policies and procedures. This fast-paced and highly intense research environment requires management ofplex therapeutic interventional (TI) trials and clinical research studies involving a very vulnerable and sick population. Therapeutic Interventional (TI) trials are treatment studies that involve people who have a disease or underlying condition. They include the administration and testing new treatments or new ways of using existing treatments, such as new drugs, vaccines, Cell Therapies, Devices, or experimental approaches to surgery or radiation therapy. The OHSU Knight Cancer Institute has multiple openings available for Data Manager (TI Sr Clinical Research Assistant) positions in the areas of:

• Transplant and Cell Therapy
• Lymphoma
• Acute Leukemia

Your application will be conered for various positions across Knight Clinical Research Management. If a suitable open position is not immediately available, your application will be retained for coneration for future positions. Function/Duties of Position: This Therapeutic Interventional (TI) Sr. Clinical Research Assistant position (a.k.a. Data Manager) is responsible for the abstraction, entry, and general management of study data for clinical trials. Primary duties include ensuring accurate andplete research data is collected from clinical trial study subjects and entered into the appropriate Case Report Forms in a timely manner. This role will also assist with the coordination of clinical trial monitoring visits, data query resolution, and quality control of collected research data. To meet audit-readiness standards, the data manager will work with the study team to obtain proper investigator oversight in all relevant source documents.

• Abstraction and entry of data from patient electronic medical records and research subject charts into study databases and Case Report Forms. Maintain research subject chart with source documentation.
• Creation of study visit source documents, based on protocol and database requirements, and informing study coordinator(s) of any protocol deviation.
• Assist in development of Case Report Forms for Investigator Initiated Trials (IITs), as determined by disease team and Clinical Research Manager.
• Collaboration with the study team to resolve any data queriesentified by the study monitor, auditor, or other indiual reviewing the study data. Work with the study team to correct any quality control issues with the data entry.
• Coordination of study monitor visits and assisting the study monitor with any data entry queries.
• Support periodic coverage to and across study teams, as delegated by the Clinical Research Manager. This includes, but is not limited to: assisting with maintaining regulatory documents, patient visits and study assessments (e.g., ECGs, vitals, specimen collection, management and shipping, etc.), requesting medical records, and other study related tasks, as needed.

Every Knight Cancer employee is expected to embody our ging principles:

• We act BOLDLY—Breakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently.
• We SUPPORT each other—Respect leads to trust, which leads to excellence.
• We work as a CONNECTED team — We must leverage our collective brain power to conquer cancer because no one indiual can do it alone.

Required Qualifications: Education and experience: Bachelor s Degree in relevant field and 1 year of relevant experience OR Associate s and 3 years of relevant experience OR No degree and 4 years of relevant experience OR Equivalentbination of training and experience. Requiredpetencies:

• High degree of attention to detail
• Ability to prioritize andplete multiple tasks at one time
• Excellentmunication, analytical and organizational skills: both written and verbal.
• Ability to work independently and as part of a team while being collaborative in resolving problems.
• Proficiency withputers running Windows and PC applications (e.g. MS Excel, Oracle, Access, Word and PowerPoint).
• Demonstrated excellent customer service skills both on the phone and in person
• Possess energy and drive to coordinate multiple projects simultaneously
• Ability to use tact and diplomacy to maintain effective working relationships
• Critical Thinking skills
• Time management skills

Preferred Qualifications:

• 1 to 3 years of relevant experience with data entry
• Ability to track progress and update others on status of data collection
• Clinical trial knowledge with a minimum of 1 year research experience
• Medical Terminology
• Working knowledge of Epic
• Typing 40+ wpm
• Familiarity withmon Electronic Data Capture (EDC) systems such as iMeata RAVE and Oracle Inform

Additional Details: Apply online at the OHSU Jobsite. Please be sure to include a resume or CV and cover letter with your application. #LinkedIN #knightclinicalresearchjobs #knightcancerjobs All are wee: Oregon Health & Science University values a diverse and culturallypetent workforce. We are proud of ourmitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Indiuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable amodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.

• Company Name : Oregon Health Science University
• Open Position : Data Manager Therapeutic Interventional TI Sr Clinical Research Assistant | Oregon Health & Science University
• Location Job : Portland, OR 97239
• Country Job : US

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