Clinical Research Associate I Job at Abbvie in Sydney NSW
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Title: Assistant Clinical Research Associate
The position addresses study related clinical site issues with appropriate guidance, initiates and communicates corrective action as indicated. They will use functional expertise and exercise good judgment in seeking appropriate guidance and ensure that follow-up to any and all corrective action taken is properly documented to ensure the safety, welfare and rights of patients are protected.
Supports the organization, management and execution of projects, ability to identify nonadherence and ensures the clinical trials are conducted, recorded, and reported in accordance with the protocol, federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
Understands the rationale and necessity for compliance to ensure protection of the safety, welfare and rights of patients. May require guidance/oversight to manage effectively. Actively participates in the study startup activities and site opening activities as well as study conduct and site closure tasks.
Manages the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas, with appropriate supervision.
Ensures integrity and quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and followup for all safety events by site personnel. Expectation to conduct independent visit. (at least 3-6 months of clinical research experience in monitoring is required or if inexperienced when joining Abbvie 3-6 of accompanied visits are required.
Supports and/or conducts on-site and off-site monitoring visits such as site qualification, initiation, interim monitoring and study closeout visits for Phase 14 studies in accordance with local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes, if applicable.
Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members. Appropriately escalates serious or outstanding issues.
Facilitates Quality Assurance Audit processes as indicated. Ensures regulatory inspection readiness at assigned clinical sites. Reports monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, with appropriate supervision.
May support with Clinical Trial Application submissions, including relevant informed consent local changes and translations into local language as required. May assist in study budget preparation and clinical study agreement execution, including ensuring necessary payments are made according to executed agreements. Negotiates investigator/ hospital agreements with stakeholders.
Maintains and completes own expense reports as per local and applicable guidelines. Support continuous improvement and innovation embracing change through the successful implementation of initiatives, processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations and conserve overall departmental operating costs.
Supports implementation of Abbvie ‘White glove service’ culture for stakeholder management to include Investigative sites. Successfully implement the Abbvie behaviors and has a positive team (stakeholder) engagement.
Appropriate lifescience or healthcare¬related life-science, health care related or relevant experience or equivalent work experience.
One year of clinically related experience in a medical profession, pharmaceutical, or diagnostic company is preferred. Current knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials is preferred
Knowledge of conducting industry sponsored clinical research (e.g. Clinical study coordinator/ data manager, clinical trial assistant (or equivalent), regulatory document specialist) is preferred. Knowledge related to ICH/GCP Guidelines and applicable local regulations is preferred.
Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address studyrelated clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated.
Ability to use functional expertise and exercise good judgment.
Demonstrated business ethics and integrity.
Yes, 25 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Company Location: Sydney NSW