Clinical Trial Specialist
A new opportunity has arisen for a motivated and experienced Clinical Trial Specialist to join our growing global Clinical Research Organisation team in the United States (US). This role provides ongoing site management to ensure project completion across the clinical trials conducted by George Clinical in the US.
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:
• Assists in coordination of feasibility process for proposed and assigned trials with activities that could include the following:
- - Identifies site list for blinded and un-blinded feasibilities as requested by CTM, PM or Clinical Operations teams
- - Manage distribution, collection, and tracking of signed CDAs when appropriate during feasibility process
- - Maintains database of site information from feasibility questionnaires (FQ Database), including site profiles for George Clinical investigator database as appropriate
- - Serve as primary point of contact during feasibility process to drive study feasibility to decision points according to established timelines
- - Provide ongoing reports and updates to the project team during feasibility process according to required timelines and project deliverables
- - Work with PM/CTM to develop final reports and recommendations of sites for Qualification Visits
- - Present final results as required to PM team and/or Sponsor
• Provides ongoing site management to ensure project completion within designated timelines
- - Works with projects managers to provide support to sites to facilitate accruals to studies
- - Maintains database of accruals for each study and site
- - Contacts study sites on a regular schedule to obtain feedback on study procedures and identification of site-specific problems
- - Address and/or triage questions from the sites
- - Maintain consistent communication with CRAs and PM regarding site updates and communication
- - Record site communication as per SOPs and/or project plans
• Establish and maintain the Trial Master File (TMF) via hard copy and/or shadow or eTMF as assigned by project.
- o Upload and maintain TMF files and folders in Vector’s file-sharing system by project, as assigned.
- o Collect essential documents from sites on designated schedule
• IRB Submissions
- o Prepare Central Study level IRB submission
- o Serve as primary contact for Central IRB as assigned
- o Prepare and submit site IRB submission packages
- o Manage IRB submissions as applicable
- o Review, confirm accuracy of approved IRB documents
• Essential Documents – Site Startup
- o Collect Essential Documents from site during site startup
- o Compile / prepare Essential Document Package (EDP) for regulatory readiness
- o Submit final EDPs to sponsor or PM/CTM as required
- o Serve as second reviewer (QC) of EDP for fellow CTS
• Ensure quality product deliverables at all times
• Setup and manage Study Portal, as needed/if applicable
• Setup and manage trackers as assigned by PM/CTM
• Maintains a professional approach respecting the dignity and confidentiality of associates, manager, and vendors
• Interfaces internally with other departments as needed, including but not limited to, Data Management, Monitoring, and Clinical Trials Finance
• Interfaces externally with study sponsors and study sites
• Attends staff meetings as scheduled
• Record meeting minutes as needed by PM team
• Provide ongoing support for PM/CTM to help develop and/or maintain assigned forms, logs, or other site materials
• Assemble and prepare shipments for site study materials
• Interface with project vendors as needed
• Performs other job functions as needed
• Provide data entry support for the investigator payment database by project, as assigned and with input from appropriate PM/CTM.
• Perform data entry functions as assigned for clinical trials (i.e., Investigator Initiated Trials (IITs)
Associates degree; healthcare related preferred and three years of healthcare research experience required; OR 4 years work related experience and/or training.
Two years of work experience in clinical research experience preferred; oncology experience preferred.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
• Must have exceptional communication skills in both verbal and written form
• Must be skilled in working independently as well as working as part of a team
• Must be proficient with the following software: Word, Excel, Power Point and Adobe Acrobat
• Must be able to prioritize multiple projects and coordinate these efforts
• Must be able to maintain confidentiality of information and procedures developed
• Must be able to work on complex projects involving various research and ancillary entities
• Must be able to promote a positive customer service image and maintain positive working relationships with internal and external customers
• Must have an understanding of GCP/ICH guidelines and FDA regulatory requirements
• Ability to sit, stand, walk, reach, climb or balance, stoop or crouch, hand/wrist use, talk, see and hear for extended periods of time
• Ability to lift up to 25 lbs.
• Travel may be required
Our preferred candidates will be based in Overland Park, Kansas with full working rights in the United States.
On offer is a competitive compensation and benefits package, flexible working options and sound learning and development opportunities.
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We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.