Clinicial Reseach Coordinator Sr.
Rockledge, FL 
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Posted 17 days ago
Job Description
Overview

The US Oncology Network believes local cancer care is better care and in 2017 Vantage Oncology joined The US Oncology Network. The US Oncology Network empowers the delivery of advanced integrated cancer care through our network of independent physicians who share expertise and resources to provide quality, value-based care close to home. Our clinical and business support capabilities, expertise and industry-leading technologies keep local practices at the forefront of high quality, efficient care delivery while enabling practice success, quality of life and financial security for physicians.

We have an immediate opening for a Sr.Clinical Research Coordinator

Scope: This is a senior-level exempt position - Responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials. Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers, and participated in required training and education. Responsible for the education and training of clinic staff as well as resource for problem solving of complex issues for the implementation of the research process throughout the clinic; process improvements, SOPs. Compiles and reports protocol activity; accrual data, financial information. Train staff and promote professional development of staff. Resource for creation of SOP's and operational plans. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.



Responsibilities

Key Responsibilities Screens potential patients for protocol eligibility:

  • Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials.
  • Coordinates patient care in compliance with protocol requirements.
  • Maintains investigational drug accountability and disbursement of investigational drug.
  • Oversees the preparation of orders by physicians to assure that protocol compliance is maintained.
  • In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
  • Responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel.
  • Oversee subject recruitment and study enrollment goals.
  • Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
  • Maintains regulatory documents in accordance with USOR SOP and applicable regulations.
  • May collaborate with Research Site Leader in the study selection process.
  • Participates in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite.
  • Provide leadership in determining and implementing improvements to policies/processes. Serve as a resource to train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans.
  • May train staff and promote professional development of staff.
  • Responsible for compiling and reporting protocol activity, accrual trends, data entry compliance, and research financial information to practice administration and physicians.


Qualifications

Minimal Job Qualifications :

- Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.

-Minimum seven years of experience in a clinical or scientific related discipline required.

-Minimum five years of oncology and/or research experience preferred.

-SoCRA or ACRP strongly preferred.

-Business Experience

- Experience in Microsoft Office Previous management and/or leadership experience preferred Specialized Knowledge/Skills

- Experience working in clinical research is preferred

-Must have excellent communication skills

-Strong ability to multi-task

-Excellent time management skills

-Must have strong interpersonal skills to be able to interact with multiple people on many different level-

-Must have a high level of attention to detail

-Must be able to work in a fast-paced environment

-May be responsible for basic clinical assessments

Working Conditions: Environment (Office, warehouse, etc.) - Traditional office environment 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. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.

Physical Requirements (Lifting, standing, etc.) - Large percent of time performing computer based work is required. 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. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)


The US Oncology Network is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Associate Degree
Required Experience
7+ years
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