Position Details


Position Title: Research Coordinator Drug Development Unit

Location: Colonial Location

This job description does not constitute an offer of employment or employment contract.

Individuals responding to job postings are considered to be applicants for a particular position only after they have been invited to complete the company's official printed employment application form. Florida Cancer Specialists is an equal opportunity employer.

 

Reports to:   Director of Clinical Research
 
Position Summary:   Responsible for the performance of the research study under the medical supervision of the Principal Investigator and the clinical research director. The clinical research coordinator is responsible for the overall successful implementation and ongoing site management of the clinical research studies.
 
Required Qualifications:  RN with a minimum of two years of oncology nursing experience and clinical research experience is required. Candidates should have effective communication skills, be organized, detail oriented, and strong patient advocates. Candidates must be available to travel to investigators meetings. Valid Florida’s Drivers License for travel to clinics. Must comply with the FCS Driver Safety Operations and Motor Vehicle Records Check Policy
 
 
Key Performance Area: 
 
  1. Responsible for the successful implementation and ongoing management of clinical trials in conjunction with FCS standards, protocols, guidelines, and policies and procedures as well as site-specific policy and procedures.
 
  1. Work with the appropriate physician. office, hospital, or FCS personnel to ensure adequate equipment, supplies, and services are available to the clinical research program.
 
  1. Access and analyze data in order to present operational reports to the PI, hospital liaisons, or FCS Senior Management in order to ensure continued success of the clinical trial.
 
  1. Ensure that the FCS trials are in compliance with Good Clinical Practices and the Code of Federal Regulations.
 
  1. Develop and implement action plans for improvement as necessary and maintain open communications in a matrix model to PI, FCS, or various liaisons outside FCS in order to enhance operational efficiencies.
 
  1. Attend all study initiation meetings.
 
  1. Coordinate the performance of all study-related activities according to protocol.
 
  1. Coordinate the study under the direction of the Principal Investigator and the Director of Clinical Research.
 
  1. Work with investigators to meet or exceed study enrollment benchmarks.
 
  1. Read and comprehend the protocol, investigator’s brochures, case report forms, and other study materials.
 
  1. Prepare source documents and other study aides.
 
  1. Screen patients to identify potential subjects according to the inclusion/exclusion criteria of the study.
 
  1. Ensure Institutional Review Board approval has been obtained before implementing protocol amendments.
 
  1. Verify that proper informed consent for each study patient is obtained prior to any study-related procedures being performed.
 
  1. Coordinate the study in accordance with the protocol, making changes only after obtaining PI approval and notifying the sponsor. 
 
  1. Ensure that the investigational drug is received, stored, and documented, and excess materials are returned to the sponsor or central research office according to sponsor guidelines and in accordance with Code of Federal Regulations.
 
  1. Complete all required documentation.
 
  1. Verify source documentation completion at the time of the visit and completion of the Case Report Forms/remote data entry.
 
  1. Meet with monitors at all scheduled visits. The clinical research coordinator will arrange time in their schedule to make corrections as necessary.
 
  1. Ensure that adequate and accurate records are maintained and make those records available for inspection.
 
  1. Ensure that the case report forms and source documentation are completed in a timely and accurate manner.
 
  1. All study related documents (i.e. drug accountability log, temperature log, calibration log, screening log, etc.) must be completed and updated according to policy.
 
  1. Ensure that all serious adverse events or other study events are communicated to the PI.
 
  1. Provide patients with written communication about participation in the study (i.e. informed consent).
 
  1. Ensure that all Serious Adverse Events are reported, as required by the sponsor, FDA regulations, and the IRB, according to FCS.
 
  1. Occasional attendance by the CRC at investigator meetings is required.
 
  1. Represent the company at all times in a professional manner. A professional appearance should be maintained at all investigator meetings.
 
  1. Supervise scheduling of all appointments and ancillary visits in accordance with the protocol.  Promptly report completed visits by means of the appropriate form to the sponsor, CRO, and FCS financial administration. Notify sponsor/CRO of any scheduling difficulties, which requires the patient to deviate from the schedule protocol visit requirements.
 
  1. Conduct subject visits in a professional manner.
 
  1. Available to answer or obtain answers for any questions the patient or their families might have.
 
  1. Act as advocate for the subject in response to all study related activities.
 
  1. Distribute medication and perform other medical tasks as required by the protocol.
 
  1. Accountable for performing duties according to the Standards of Nursing Care.
 
  1. Track lost to follow-up subjects according to FDA guidelines and FCS policy.
 
  1. Keep work area and records in a neat and orderly manner.
 
  1. Comply with all Federal and State laws and regulations pertaining to patient care, patients’ rights, safety, billing, human resources and collections. Adhere to all FCS and departmental policies and procedures, including IT policies and procedures and Disaster Recovery Plan. 
  2. Maintain all company equipment in a safe and working manner.
 
  1. Maintain and ensure the confidentiality of all patient and employee information at all times as required by the HIPAA regulations.
 
  1. Assist in training new employees to related job duties.
 
  1. Will be expected to work at any FCS location to help meet FCS business needs.
 
  1. Will be expected to work overtime when given sufficient notice of required overtime.
 
Expectation for all Employees:
Support the organization’s mission, vision and values by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect, personalization, commitment to our community, accountability and ownership.      
 
This job description in no way states or implies that the listed duties are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instruction and to perform other job-related duties requested by their supervisor or other management personnel. Other duties may be assigned to meet business needs. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.     
 
Essential Physical Requirements:
·        Ability to travel independently throughout the facility to access information from other departments.
·        Ability to sit for long periods of time.
·        Ability to operate an automobile for travel to other offices.
·        Ability to reach, grasp, type, bend, stoop, talk and hear.
·        The work is performed in a typical office environment.
·        This position requires sitting for long periods of time, requires hand-eye coordination, and manual dexterity to operate a telephone, computer, calculator, and other office equipment.
·        Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
 
 
 
 
Essential Mental Requirements:
·        Ability to work under stress, with interruptions and deadlines.
·        Ability to process verbal information and input this information into computer system.
·        Ability to follow complex instructions.
·        Ability to master advance math skills.
·        Ability to think logically in following procedures and instructions.
·        Ability to think logically and make decisions.
·        Ability to utilize the FCS information system.
 
Essential Technical/Motor Skills:
·        Ability to enter and retrieve data from computer.
·        Ability to operate modern office business machinery.
·        Ability to operate phone system.
 
Essential Sensory Requirements:
·        Ability to converse in calm and friendly manner.
·        Ability to view data on the FCS information system and in various written formats.
·        Ability to communicate on the phone.
Interpersonal Skills
  • Ability to effectively communicate and interact with coworkers, companies sponsoring research studies, insurance company staff, hospital staff, patients, public, physicians and their staff.