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Senior Clinical Research Associate

2 weeks ago

Perth, Western Australia One Clinical Research Full time $90,000 - $120,000 per year

One Clinical Research (OCR)

OCR is a leader in conducting cancer clinical trials, specialising in pharmaceutical industry-sponsored clinical trials for patients with haematological (blood) or solid-organ cancers.

The successful candidate will be primarily responsible for the review and oversight of clinical trials conducted at OCR, with a strong focus on supporting study team members to ensure adherence to protocol and sponsor requirements, as well as OCR standards and processes to ensure high data quality and timeliness. This role is integral to maintaining the integrity and success of clinical research activities within OCR.

To excel in this position, the candidate must possess a solid foundation in clinical trial management, including monitoring and data management processes. Key responsibilities for the SCRA include verifying source data against protocol requirements and case report forms (CRFs) to ensure accuracy, completeness, and data integrity throughout the trial lifecycle, as well as independent review of ISFs.  The SCRA will have experience working in a similar capacity, have excellent knowledge of standards, procedures and regulations relating to clinical trial conduct, strong understanding of ICH-Good Clinical Practice, and relevant local regulations. The SCRA will assist the Quality and Development Manager in the management of internal and external audits/inspections, CAPAs / RCA and QMS processes, as well as contributing to the development of relevant quality documents (e.g. SOPs).

This position will join a close-knit team passionate about optimising patient outcomes in an innovative and progressive clinical trial setting, engaging with various stakeholders to ensure high-quality and efficiently conducted clinical trials, helping to advance access to better treatments for those with cancer.

Essential Criteria:

·       Bachelor's degree in related discipline, preferably in life science, or equivalent qualification

·       Minimum 2 years' experience working at Senior CRA level with independent site monitoring experience

·       In-depth knowledge of clinical trial management, source data verification, and CRF and ISF review

·       High-level information technology and computer skills including competence in document preparation in Microsoft Office and Adobe

·       Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH-GCP, TGA) and legislation relating to clinical trial conduct

·       Excellent analytical and problem‐solving, and decision-making skills with a solutions-focused mindset

·       Excellent organisational and interpersonal skills

·       Ability to work effectively in a fast-paced, team-oriented environment

Desirable Criteria:

·       Previous auditing experience, and experience with RCA and CAPA management

·       Experience with electronic QMS systems

·       Experience working within a risk‐based monitoring approach including remote monitoring

·       Experience in electronic source documentation/eISF

·       Understanding of medical terminology (ideally oncology or haematology context)

·       Ability to look for and champion continuous improvement to deliver high quality trials

·       Ability to effectively collaborate with cross-functional study teams to ensure regulatory and sponsor compliance

·       Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines

OCR offers competitive salary options commensurate with experience and responsibility, along with good work-life balance with options for remote working (where appropriate) and flexibility.

To apply: Submit a cover letter (that details your working hours/FTE preference) and current CV via Seek.

You must be based in Western Australia, and demonstrate the right to work in Australia to be successful in obtaining this position. Please note that only candidates successful in gaining an interview will be notified.

CLOSING DATE: Interviews will be conducted as applications come in so apply early

For enquiries, please contact management