Site CRC 1 - FL/CA in Orlando, FL at Apex Life Sciences

Date Posted: 6/6/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Orlando, FL
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    6/6/2018
  • Job ID:
    855958

Job Description


CRC - Orlando

PURPOSE:

  • To work as an integral member of partner/investigator site staff maintaining the day-to-day relationship with a partner site/s involving:
    • planning,
    • scheduling patients for a hub and spoke model,
    • creating interest with patients,
    • coordinating community activities
    • and, as appropriate, execution of clinical studies in accordance with the protocol, contracted scope of work, ICH/GCP, Sponsor/CRO's SOP's and any relevant local guidelines and regulations.

RESPONSIBILITIES:

  • Work directly at patient/subject interface at investigator sites to deliver high quality patient data in accordance with local regulations, agreed scope of work and as required by protocol.
  • Assist Investigator with Feasibility questionnaire completion and return.
  • Facilitate timely startup of all studies at the site by ensuring timely completion/submission of regulatory documents and ethics approvals and IP release documents.
  • Attend and participate in monitoring visits, audits, seminars and other regional or national meetings.
  • Assist with screening and enrollment of subjects into assigned studies.
  • Support subjects on trials to encourage maximum retention and future recruitment.
  • Assist with the establishment of a recruitment and contingency plan for each study.
  • Perform functions necessary for successful completion of all protocol required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the investigator, in accordance with local country requirements.
  • Accurately complete source documents and case report forms in both paper and electronic format.
  • Assist investigator with recording and reporting of adverse events as per local regulatory authority guidelines.
  • Ensure documentation of data protection agreement is on file for assigned site (Nurse Honorary contract, Master CRC Services Agreement or other such documentation) where necessary and in accordance with local country requirements.
  • Perform other duties as assigned.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

  • Good knowledge of medical terminology.
  • Above average interpersonal and organizational skills.
  • Proficient in the use of Microsoft Office.
  • Fluent in local language, spoken and written.
  • Fluent in written English language.
  • Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
  • Ability to maintain confidentiality.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Experience with imaging (Fibroscan) is strongly preferred.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

  • Licensed Medical Assistant, Certified Nurse Assistant, Registered nurse, medical physician or appropriate educational qualification and 1 years' experience.

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.