Clinical Research Associate for our Sydney Office - [A659]

Clinical Research Associate for our Sydney Office - [A659]

03 Sep
CTI Clinical Trial and Consulting Services

03 Sep

CTI Clinical Trial and Consulting Services


Clinical Research Associate

Job Purpose/Summary

(Level Depending on Experience)

Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonization (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

What You’ll Do

- Serve as main CTI contact for assigned study sites

- Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV],

and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP

- Assist with study start-up activities, including feasibility, pre-study activities and site selection

- Collect, review and track essential/regulatory documents

- Participate in and complete all general and study specific training as required

- Participate in investigator, client and project team meetings

- Create and implement subject enrollment strategies for assigned study sites

- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials

- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager

- Conduct remote monitoring and complete the related activities in accordance with study specific Monitoring Plan

- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP

- Assist with project-specific activities as member of Project Team

- May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)

- May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures

- Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. Provide regular updates to Sponsor/ Client

- Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments

- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans

- Identify site issues and implement corrective actions or escalate as appropriate

- Liaise with Clinical Data Management for data cleaning activities

- Assist in preparing and coordinating Investigator and client meetings and attend meetings as necessary

What You Bring

- Excellent verbal and written communication skills

- Excellent organizational and time management skills

- Strong critical thinking and decision-making skills

- Excellent collaboration, customer service, and interpersonal skills

- Ability to work independently

- Proficient in use of laptop computer and software systems, including Clinical Trial Management (CTMS), electronic Trial Master File (eTMF), electronic Data Capture (EDC), or similar systems

- Ability to understand complex medical terminology and procedures

- Ability to monitor complex studies

- Knowledge of ICH/GCP and all applicable regulatory requirements

- Experience in clinical trial monitoring or equivalent experience as determined by CTI Management and Human Resources

- Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources

- Previous experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO

Why CTI?

At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.

For that reason, we treat our team members with the respect they deserve, and our numbers show it:

- We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward

- We value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department

- We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.

- Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area , as well as one of the top CROs in the industry

- We think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.

- We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs

- Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

After an appropriate period of training, we offer you an unlimited, varied and attractive job in an international company.

Are you interested? Then we look forward to your electronic application, with a tabular CV in English.

CTI Clinical Trial and Consulting Services

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