Senior CRA I / II

We’re looking for experienced Senior CRA’s to join our team. You will be based from home anywhere in Victoria or New South Wales.

We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field and you’ll recognise that we’re a growing organisation.

Why should you join Avance Clinical?

We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We’ve doubled in size over the last 3 years and have promoted 23% of our people in the last 12 months.

Opportunity

We have full-time, permanent positions for experienced Senior Clinical Research Associates to join us.

The Senior Clinical Research Associate I (SCRA I) perform assigned trial related duties and functions ensuring the trial is conducted in accordance with the protocol; company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. Responsibilities include service provision, departmental systems and procedures support and reporting and may include mentoring of junior team members.

Responsibilities

• Conduct site and investigator feasibility activities.
• Develop study-related documents or plans under the supervision of the study Project Manager.
• For a multi-site study, oversee and lead the operations of the clinical team as the Lead CRA including development of Clinical Monitoring Plan, study-specific annotated report, reviewing Visit Reports.
• Perform all activities (preparation, execution and follow-up) associated with onsite or remote Pre-Study Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV) and Close-out Visits (COV).
• Generate and maintain high quality confirmation letters, site visit reports, follow-up letters and other documentation related site monitoring and management to ensure compliance with ICH GCP, study protocol and regulatory requirements.
• Monitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability, meet with site personnel and ensure procedures are conducted in accordance with the protocol and ICH GCP.
• Perform protocol review as requested.
• Raise data queries in the Case Report Form (CRF) where discrepancies are identified and work with site staff to ensure timely and accurate resolution.
• Collect TMF documentation from site and ensure accurate and timely filing as per SOP requirements.
• Maintain effective site communication to proactively manage on-going study expectations and issues.
• Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
• Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.
• Provide guidance and mentoring to less experienced staff during co-monitoring visits and facilitating accompanied site visits.

Requirements

• Bachelor’s level degree in life sciences, pharmacy, nursing or equivalent field.
• 5 plus years experience as a CRA / SCRA within a CRO.
• Formal ICH GCP training and a working knowledge of ICH GCP Guidelines and other applicable regulatory requirements.
• Clear understanding of the requirement to adhere strictly to client confidentiality.
• Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
• Demonstrated ability to take initiative in problem solving and in exercising good judgment.
• Awareness of Privacy Legislation as it applies to the Clinical Trial environment.
• Ability to work under pressure in a multi-disciplinary team environment.
• Willingness to work in, and be supportive of, a positive and dynamic team culture.
• Ability to travel. Moderate level of interstate travel may be required (up to 50%).

What next?

As a growing business we’re looking for likeminded people to join us - we hope that’s you.

• To join our team please submit your CV & cover letter as one Microsoft Word document
• You must have full Australian working rights to be considered as we're unable to offer sponsorship for this role.

At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.

CRA / SCRA / Clinical Research / CRO / Clinical Trials / Sydney / Melbourne / Remote / Work from home