TI Clinical Research Assistant (Clinical Research Coordinator)

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 provided through proactive, high quality and efficient study management in compliance with federal regulations and local policies and procedures. This fast-paced and highly intense research environment requires management of complex 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, or Cell Therapies.

Function/Duties of Position

This Clinical Research Assistant is responsible for assisting with various duties to facilitate oncology clinical research on the Phase 1 team in the Knight Clinical Research Management organziation. 

 

OHSU classification: Therapeutic Interventional (TI) Clinical Research Assistant (R03)

 

This Clinical Research Assistant will collaborate with the study team to:

• Assemble initial patient charts
• Courier and coordinate study related medications from pharmacy to the patient during their visit
• Facilitate completion of quality of life questionnaires with patient during their visit
• Perform electrocardiogram on patients during their visit
• Assist with patient data entry into a database or web based applications
• Collect data for case report forms and queries
• Abstract basic data from medical records, process/ship specimens, contact of patients for survival info;
• Order medical records for clinical trial reporting
• Assist in the maintenance of regulatory documents and obtain signatures.

 

Depending on experience, this position may also coordinate non-treatment-related oncology studies and/or oncology-treatment-related studies that have patients in active or long-term follow up with oversight by Clinical Research Manager or senior study coordinators. This position will assist the Clinical Research Manager with other projects as needed.

 

The CRA will be expected to obtain and maintain a working knowledge of National Cancer Institute (NCI), FDA, DHHS and other agency guidelines that govern oncology clinical research. Additionally, the CRC is required to learn the basics about the oncology diseases that their team manages and know how to apply this knowledge to the tasks they manage. The CRA is also required to have a basic understanding of the study financial lifecycle and how their work directly impacts this.

 

Given the complexities of oncology research and the challenges of working with a terminally ill population, strong customer service, organizational, and interpersonal skills are required.  Ability to clearly organize and/or adapt to multiple priorities and deadlines at one time is necessary.  Attention to detail, service orientation, and above average critical judgment skills are essential. Requires supervision; able to complete responsibilities with oversight; performs routine clinical research tasks (e.g., tissue sample management, medical record acquisition, specimen processing); some innovation and problem solving.

 

Under general supervision, assists in coordinating the details of therapeutic interventional research studies and protocol documentations, patient scheduling, and data collection. Assists in complex studies.

Required Qualifications

Education & experience:

• Bachelor's in relevant field and no experience OR
• Associate's AND 2 years of relevant experience OR
• 3 years of relevant experience OR
• Equivalent combination of training and experience.

Knowledge, skills, and abilities:

• Ability to prioritize multiple tasks at one time
• Excellent communication, 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 with computers running Windows and PC applications e.g. MS Excel, Word and PowerPoint
• Excellent customer service skills
• Ability to work with a variety of diverse individuals and personalities
• Energy and drive to coordinate multiple projects simultaneously
• Ability to use tact and diplomacy to maintain effective working