Our company is expanding and we have a great opportunity for a phase I, single site, contract CRA assignment in NAFLD/NASH.
We have recently approved additional CRAs for our team, and you can choose your allocation either 80-100% allocated Blinded CRA co-monitor (8-12 days on-site per month) or 15-30% allocated unblinded CRA co-monitor (2-5 days on-site per month that you work). The site monitoring will start remotely, and when on-site work is allowed, any on-site monitoring will be completed within Melbourne.
We are looking for experienced CRAs, who currently live in Melbourne, or within a 6-hour round trip drive, no exceptions. The contract duration is through Dec 2021, and it may be renewable. Please read the rest of the job info, and do not apply if you lack the prior experience required or living proximity. This position is qualified as contractor 'travel necessary for permitted authorized health service.
If you want to work with a passionate research company in the pharmaceutical, biotechnology, and device industries, look no further. We are rapidly expanding, have a huge passion to change lives, and want to be in business with like-minded people. If you meet the qualifications and this sounds like you, apply today! Please fill out the intro application survey sent via email after you apply. thank you!
- Generally, the report writing duties will fall to other team members. In some cases, you may need to arrange time away from data monitoring to write the report with your CTM
- The site monitoring may potentially start remotely (i.e., 4-5 remote visits per week), but be prepared for those visits to turn into on-site visits when this is allowed by Victoria. The present amount of data requires this to be a data monitoring-focused contract
- All on-site monitoring is completely within Melbourne, so the candidate must currently live in Melbourne, or within a 6-hour round trip drive completely inside Victoria. As with most CRA roles, you will conduct on-site monitoring of the clinical research study according to the client’s Standard Operating Procedures (SOPs), Therapeutic Goods Administration (TGA), and International Conference on Harmonization-Good Clinical Practices (ICH-GCP) guidelines
- You will start remotely with a number of training modules, you must attend scheduled meetings or provide notice if you cannot attend
- May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, and close-out visits of clinical sites, and maintenance of study files, with or without guidance
- May conduct other visits if required by the client
- Ensure the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Identify, track, and follow up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensure all applicable SAEs are reported to sponsor and regulatory authorities.
- Ensure the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, by comprehensive source document review. Monitor study database for missing or discrepant data compared to the source record at the clinical site
- Ensure that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan)
- Maintain study blindly and act as a blinded study monitor. Conduct eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervision
- Attend investigators’ meetings, project team meetings, and teleconferences, as needed.
- Understands and applies knowledge regarding local, state, country regulations (i.e., TGA, etc.) and ICH-GCP
- Maintain training on ICH-GCP, study protocol, and client procedures
- May track regulatory documents may track recruitment, may evaluate study site quality and integrity, and may motivate assigned sites to meet client deadlines
- May create study tools, study plans, mentor staff, review line listings, and/or conduct staff training/sign off visits
- Must have 3 years (minimum) of traveling experience as a Clinical Research Associate (CRA), or sponsor/CRO-side Site Manager. (Ph.D. or terminal degree allows a minimum of 2 years' monitoring/CRA experience)
- Must have prior CRO experience (1-year minimum)
- Recent monitoring experience as a CRA is required within the last 2 years
- In addition, one of the following should apply to your experience: you are a CRA who monitored either NAFLD/NASH or another metabolic condition, and/or monitoring a phase I study, and/or an in-patient study, and/or a complex indication study
- The candidate possesses a 4-year university degree, ideally in a scientific field
- In lieu of a 4-year university degree, a candidate with 7 or more years of relevant clinical research experience, and with 5 years of monitoring in a complex indication (in-patient, oncology, phase 1, etc.) may be considered
- Must have working rights in Australia
- Must be located within Melbourne, Australia, or the metropolitan area of Melbourne, Australia (no more than 3 hours from the site one-way)
- Must be able to go on-site weekly (when permitted), as a co-monitor and back-up to the primary CRA. When on-site presence is not permitted by local regulations, the position will continue remotely
- Must have a solid understanding of ICH-GCP guidelines, local regulatory requirements (TGA), and the clinical trial process
- Must understand medical terminology, clinical research acronyms, and medical/scientific abbreviations. -CCRA or CCRP certifications are preferred but not required
- The candidate must have 95-100% availability for this contract through December 2021
- Must possess exemplary verbal skills in the English language with the ability to solve complex problems using medical terminology
- Must be proficient at tactfully and succinctly managing intra-team communication, as well as interpersonal communication with the site
- Victoria State Government permits the contractors on this study, as providers of 'the conduct of human medical research trials', to travel to the site in Melbourne to monitor this study. The maximum distance from your home office to the site allowed is 3-hours one way per study budget. 4-5 days/week commute is necessary in order to meet the data monitoring requirements for this co-monitor role.
About Caritas Clinical
Caritas Clinical is a clinical operations partner that provides highly specialized consulting services for the pharmaceutical, biotechnology, and device industries.
We chose the word "Caritas" to define our company because in medieval English Caritas was often posed as the chief concept guiding relationships, directing government, even the rule behind mathematics and order in the universe. It was the word used for "love" in the principal: love your neighbor as yourself. It is also the root of our modern English word "charity".
Caritas was not an act of compulsion, but the care one would have for family.
Bottom line - we created this company to do what we love to do: life-changing medical research; and to dedicate our time, talents, and resources to those who need them.