Oregon Oncology Specialists is seeking an experienced Clinical Research Manager to help build our Clinical Trials Program. The Research Manager will recruit and enroll patients, ensure adherence to trial protocol and IRB guidelines, and collect and report data. The position offers the opportunity to work with physicians, clinic personnel, the research team, and patients as well as to coordinate all protocol related tests, procedures, and visits. The ideal candidate will be self-motivated, detail-oriented, experienced in research, and excited for the opportunity to help establish our research program.
ESSENTIAL JOB FUNCTIONS:
Facilitates recruitment to cancer clinical trials by screening scheduled patients for basic eligibility criteria. Ensures patients are informed of available clinical trials
Screens patients to assure appropriate patient selection according to specific protocol inclusion and exclusion criteria
Facilitates the informed consent process and evaluates patient eligibility for participation in a cancer research study with the principal investigator
Uses expert nursing judgment to maintain the integrity of the research protocol in accordance with federal regulation and good clinical practice (GCP) guidelines, and coordinates care to ensure the compliant conduct of the trial while maintaining patient safety
Coordinates with IRB to ensure research protocols meets IRB requirements
Serves as the point person and team leader for assigned research projects, in conjunction with primary investigator
Retrieves data from patient charts and/or source documents for entry into sponsor provided case report forms. Case report form may be paper based or electronic
Works with physicians, clinic personnel and the research team to coordinate all protocol related tests, procedures, and visits
Prepares and maintains source data documents
Assists with patient scheduling as needed, coordinating appointments with other providers associated with protocol care (i.e. x-ray, scans)
Ensures all study-related data, files, and samples are stored and reported according to protocol
Additional duties include:
Promotes a proactive and professional relationship with external affiliates regarding clinical research.
Maintains strictest confidentiality
Attends meetings and /or training as required
Other duties may be assigned
Education and Experience:
Nursing degree (Baccalaureate, Associate or Diploma) from an accredited school of nursing
Current RN License in State of Oregon
At least one-year experience in Oncology (Preferred)
Experience working as a clinical research nurse or coordinator (1yr minimum, 3yr preferred)
Knowledge of current FDA regulations, and Good Clinical Practices (GCP’s), governing clinical research.
Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) certified (preferred)
Knowledge of Oncology practice and terminology as well as clinic policies and procedures
Ability to prepare records in accordance with detailed instructions
Understands ethical & legal liability, and patient safety issues associated with non-compliance with regulations governing research
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, trial protocols, and procedure manuals and examine documents for accuracy and completeness
Speaks clearly and concisely, communicates effectively, and works cooperatively with co-workers, patients, and business contacts
Independent and self-motivated
Enjoys and feels a sense of accomplishment with completion of repetitive tasks and “paper-oriented” work
Detail-oriented, precise and accurate
Proven track record of working well within a team, with other businesses, and with the public
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals as well as compute rate, ratio, and percent and to draw and interpret bar graphs
Competency in Microsoft Office
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position is in a standard medical office environment with desktop business equipment and frequent telephone calls. There may be frequent interruptions and high utilization on some days and low utilization on others. The noise level is moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work is typically performed in a medical office environment. While performing the duties of this job, the employee is regularly required to: use hands to handle, or feel; talk; see; and/or hear. Employee must be able to work in close contact with small and large groups. The employee frequently is required to sit; stand; walk; bend; twist; use hands to write, finger, handle or feel; and reach with hands and arms. Employee will also regularly be required to read and write.
About Oregon Oncology Specialists
At Oregon Oncology Specialists, we are dedicated to providing the highest quality care. Our physicians are highly trained experts who treat every patient with precision, confidence and compassion.
We specialize in the latest treatments and most advanced therapies, delivering outcomes that meet or exceed even the largest cancer centers.
As a physician-owned practice, we have one mission: to provide you with medical excellence, close to home, from people who care.