This position can be worked remotely from anywhere in Australia but does require travel
A Clinical Research Associate (CRA) is responsible for conducting monitoring activities at a clinical site(s) for a clinical trial(s). The CRA may be responsible for multiple projects and must be able to work both independently and in a team environment. The CRA may also be responsible for mentoring CRAs and other Clinical Operations (CO) staff.
- The CRA will be assigned clinical monitoring activities in a single country or in several countries ensuring quality service and appropriate clinical study conduct.
- The CRA will ensure subject safety and verify diligence in protecting the confidentiality of each subject.
- The CRA shall guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes.
- The CRA will make sure that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements in the assigned countries.
- The CRA will have to anticipate, recognize and resolve issues in the served study sites and may oversee such activities of CRA/other CO staff
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- Follow Protocol(s)/Amendment(s), Standard Operating Procedures (Advanced Clinical or Sponsor SOPs) Code of Federal Regulations (CFR) Good Clinical Practice (ICH GCP), and local regulations
- Travel to research sites as needed
- Complete project-specific training and attend client meetings as needed for the clinical trial
- Act as the Lead CRA on a project as needed
- Create materials as needed to successfully execute assigned responsibilities
- Perform source document verification, source data review, review regulatory documents and investigational product, and prepare trip reports as outlined in the Monitoring Plan
- Maintains awareness of key study performance indicators for own sites including subject recruitment and retention strategies
- Ensures all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements, IP management, SAE reporting requirements
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles the ISF with the Trial Master File (TMF) to ensure audit readiness
- Review and/or input to study protocol, CRF and validation tools
- Preparation and/or review of any kind of study documents, Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form etc.
- Prepare the submission to the Independent Ethics Committees (central and local) and when applicable to Competent/Regulatory Authorities
- Assists in developing of Investigator and Institution contracts and budget template, negotiates budgets with sites and arranges site payments
- Participates to Investigators selection/feasibility: e.g. phone contacts, questionnaire in the appropriate country
- Conduct of site qualification visits (pre-study visits)
- Conduct of site initiation- and site close out visits
- Conduct of regular monitoring visits
- Ensures that the site is equipped with all necessary supplies for timely reporting and that the procedures (sampling storage and shipment logistics) are appropriately adhered to
- Writes a corresponding site visit follow-up letter for the purpose of on-site quality optimization
- Distributes any documents collected during the monitoring visit to the appropriate department (data entry, assistants for archiving etc.)
- Responsible for the quality of data from his/her own sites
- Resolves questions/issues with investigator/trial staff including query verification
- Resolves and writes Data Clarification Forms, and reviews data-listings
- Manages his/her own visit schedule, appointments and the following-up of issues between visits under, along with regular communication with the sites and the clinical study team
- Maintain close contact with the investigators on-site, the centre study coordinator the pharmacist and other involved parties to be aware of any possible patient enrolments, the enrolled patients' status, the IP stock and any further site requests or problems.
- Filing and update of study documentation in the Investigator Site File and Pharmacy File (if applicable) and the TMF or Project File within the Clinical office throughout the study.
- Review of Trial Master File (TMF) and ensure that all documents are in order, logical, accurate, complete, up-to-date and ready for a study audit and/or inspection
- Participates in relevant job/study related trainings
- Participates in investigators meetings and assists in the preparation of these meetings
- Performs activities in other clinical research areas according to the directive of superior
- Provide project specific training/mentoring to new team members
- Perform co-monitoring training with new CRAs
- The ideal candidate should have as a minimum a Bachelor's degree but a Registered Nurse (RN) may also be considered. Prefer scientific discipline and multiple therapeutic experiences
- Greater than 3 years of monitoring experience or combination of on-site monitoring and clinical research experience or education; industry certification preferred.
- The ability to perform travel up to an average of 80%, depending on project needs
- The ability to direct other CRAs as needed
- The candidate must have excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail
- The candidate must be computer literate with proficiency in MS Office including Outlook, Word, Excel, and PowerPoint as a minimum
- This role may be office and/or home-based/field-based however regular infrequent visits to a Company office will also be required.
The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:
- Applicable Standard Operating Procedures
- Good Clinical Practices (ICH Guidelines; Good Quality Practices) and local regulations
- 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidances; Computerized Systems Used In Clinical Trials)
- Good Clinical Data Management Practices
- HIPAA - Protected Health Information/GDPR-General Data Protection Regulation, as applicable
- Drug Development and Regulatory Approval Processes (depending on applicable territory(ies)
- Strong computer acumen in technology applications, including but not limited to, use of eTMF, EDC, CTMS, site EMR systems, etc.
- You must be fluent in the language of the territory you are assigned to as well as written and oral English (any additional languages would be appreciated).
- Candidates must be in possession of a current passport or identity card and a compliant and valid driving licence.
Equal Employment Opportunity
It is Advanced Group's practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.