Job Description
The role of Clinical Research Associate I is to support the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory guidelines, protocols, and quality standards. This involves site selection, initiation, and monitoring visits, reviewing study documentation and data for accuracy and completeness, liaising with site staff to address study-related issues, ensuring the safety and well-being of study participants, maintaining essential study files, and assisting in the preparation and submission of study documents.
Key Responsibilities
* Act as the primary point of contact for the investigative site, providing contextual information on the clinical trials, connecting stakeholders to the investigative sites, and strengthening AbbVie's positioning.
* Align, train, and motivate the site staff and principal investigator under supervision on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership.
* Conduct site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects.
* Customise site engagement strategy for assigned studies under supervision and gather local/site insights and utilise site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
* Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
* Develop solid knowledge of therapeutic area, asset, and clinical landscape/patient journey to enable successful patient recruitment and overall protocol compliance.
* Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
* Ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution.
* Ensure preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
* Identify, evaluate, and recommend new/potential investigators/sites under supervision and support from more experienced CRAs.
* Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
* Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.
* Report any adverse event within 24 hours as per AbbVie's policies and procedures.
* Proactively participate in AbbVie's WHS programs, adhere to policies, and promote a safe work environment at all times.
* Adhere to AbbVie's internal codes of conduct and compliance processes.
* Other ad hoc duties such as administrative duties, as requested.
Required Skills and Qualifications
* Tertiary qualification in health related discipline (Medical, Scientific, Nursing).
* Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
* Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
* Clinically related experience, preferably in clinical research coordinating or data management preferred.
* Able to work collaboratively and cross-functionally to develop and sustain working relationships.
* Demonstrate planning and organisational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
* Ability to leverage technology, tools, and resources to provide customer-centric support based on the health of the site.
* Interpersonal skills with strong written, verbal, active listening, and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
Benefits
This is an entry-level opportunity to work with a leading pharmaceutical company, recognised on the Fortune 100 Best Companies to Work For list. The role requires up to 80% travel interstate or overseas as required.
Flexibility and Availability
In line with Australia's 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.