Senior/Lead CRA - Memphis, TN | Biospace
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Senior/Lead CRA

George Clinical

Location:
Memphis, TN
Posted Date:
8/10/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Clinical Research, Research, Senior Research Associate,

Job Description


A new opportunity has arisen for a motivated and experienced Sr./ Lead CRA to join our growing global Clinical Research Organisation team in the United States (US). This role is a full-time home based position.

George Clinical is a leading clinical research organization (CRO) with staff in Australia, New Zealand, China, Taiwan, Korea, Malaysia, India, the United States and Europe - we couple the medical and scientific expertise of The George Institute with operational excellence and a truly global presence. George Clinical provides a full range of trial management services to pharmaceutical, medical device and diagnostic customers, for both registration and post marketing trials. Our parent organization, The George Institute for Global Health, is a leader in chronic disease research with a global network of experts. George Clinical combines this scientific and clinical leadership from the Institute with world class trial delivery capability to create a distinctive service. George Clinical’s internationally recognized scientific leadership allows them to provide excellence from design to delivery.

The key responsibilities for the role will include:

The Clinical Research Associate will be responsible for monitoring activities in compliance with FDA regulations, ICH/GCP guidelines, George Clinical Oncology SOPs, and sponsor SOPs. The CRA will manage the activities of the clinical investigative sites to ensure successful execution of the protocol. The CRA will also ensure that trial data are accurate, complete, and verifiable from source documents.

We’re looking for experienced CRA candidates with diverse monitoring background who can contribute to the project team through monitoring skills and also be willing and able to perform additional project supporting functions such as monitoring report template/annotation prep, review of project plans, co-monitoring, site feasibility/selection activities, presentation at investigator meetings or bid defence meeting or other project activities as needed.

Requirements


•   Bachelor’s degree in a science or related field and five to seven years related experience.
•   Relevant work experience should include at least five (5) years of Monitoring experience of which at least four (4) to five (5) of those in oncology.
•   Phase I monitoring experience required.
•   Must have a good understanding of the clinical development process and associated regulations. CCRP preferred.
•   Other Skills & Abilities:
      – CRO experience
      – Experience as Monitor
      – Experience conducting all visit types (pre-study, Initiation, Monitor Visits, and Close-out visits)
      – Oncology
      – Early Phase I/II experience (preferably in oncology trials)
      – Travel up to 75% (at least 3 days a week)

On offer is a competitive compensation and benefits package, flexible working options and sound learning and development opportunities.

Follow us on Linkedin to learn more about your future with George Clinical.

We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.