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 Job #02681 Email this job to a friend
About our client
Our client is a world leading healthcare company that has developed a reputation for successfully bringing impacting oncology products to market. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees.
Position Location
Clinical Research Coordinator III Northwest, USA
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Enlist, maintain and ensure compliance for all patients on clinical trials (under minimal supervision)
2) Collaborate with the physician in determining eligibility of patients for clinical trails
3) Educate staff and patients
4) Ensure that site research quality is in compliance with Standard Operating Procedures, Good Clinical Practice and applicable federal, state and local regulations
5) Support and adhere to the company’s compliance program, including the Code of Ethics Business Standards
6) Screen potential patients for protocol eligibility
7) Present trial concepts and details to the patients and participate in informed consent process
8) Enroll patients on protocol
9) Coordinate patient-care in compliance with protocol requirements
10) Disburse investigational drugs and teach patients regarding administration
11) Maintain investigational drug accountability
12) Review patients in collaboration with a physician for changes in condition, adverse events, concomitant medication use, protocol compliance, response to the study drug and thoroughly document all findings
13) Ensure accurate and timely data collection, documentation, entry and reporting
14) Schedule and participate in monitoring and auditing activities
15) Maintain regulatory documents in accordance with the company’s SOP and applicable regulations
16) Participate in training and educational programs (as required)
17) Guide and instruct clinical staff regarding clinical research
18) Collaborate with the Research Site Leader in the study selection process (as needed)
19) Work directly with other (non-company) research bases and/or sponsors
20) Identify quality and performance improvement opportunities and collaborate with staff in developing action plans to improve quality
21) Compile and report protocol activity, accrual data and research financial information to practice administration and physicians
22) Develop practices research budgets
23) Oversee preparation of orders by physicians to ensure that protocol compliance is maintained
24) Communicate with physicians regarding study requirements, dose modification and reporting of adverse events
25) Supervise or manage other research staff
26) Provide a safe environment for patients, their families and clinical staff at all times through compliance with all federal, state and professional regulatory standards (as issued through OSHA and the CDC)
27) Maintain strict patient confidentiality according to HIPAA regulations and applicable laws
Requirements
1) Associate degree in a clinical/scientific/related discipline (Bachelor’s degree preferred)
2) Minimum 7 years of nursing experience in clinical/scientific/related discipline (oncology preferred)
3) Minimum 2 years of supervisory experience
4) Current licensure as a registered nurse in state of practice along with current BLCS or ACLS certification
5) SoCRA or ACRP certification preferred

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