Role Description Are you an experienced Clinical Research Coordinator ready to step into a Clinical Research Associate (CRA) role—or a newly appointed CRA looking to strengthen your monitoring skills? We are seeking motivated and detail-oriented professionals to join our CRA team in Queensland. This opportunity is ideal for CRCs looking to transition into monitoring, as well as junior CRAs who are early in their careers and eager to build a strong foundation. Key Responsibilities - Performs and coordinates all aspects of the clinical monitoring and site management process, including but not limited to: source data review (SDR) and verification (SDV), visit reports, maintain accurate study documentation, identify & address site issues and action items. - Conducts on-site and remote site visits to assess protocol and regulatory compliance and manages required documentation. - Ensure trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects' rights, well-being and data reliability. - Ensures audit readiness. - Develops collaborative relationships with investigational sites. - Collaborate with cross-functional teams, including Clinical Trial Managers, Study Start-Up and Regulatory teams. Qualifications - Minimum 5+ years’ experience as a Clinical Study/Research Coordinator working on sponsor-driven trials, or an early-career Clinical Research Associate (approximately 6–12 months’ experience). - Bachelor’s degree in life sciences, nursing, or a related field. - Solid understanding of clinical trial processes and ICH-GCP guidelines. - Strong attention to detail, time management, and organisational skills. - Critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving. - Good oral and written communication skills, with the ability to communicate effectively with medical personnel. - Ability to work in a team or independently as required. - Strong computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software. - Strong English language and grammar skills. - Ability to remain flexible and adaptable in a wide range of scenarios. - Ability and willingness to travel extensively (approximately 70–80%). - Valid Australian driver’s licence and ability to travel independently to sites. - Australian citizen or permanent resident only. Benefits - Structured CRA onboarding and training program tailored to your experience level. - Mentorship and clear progression pathway to independent CRA. - Exposure to a vast variety of clinical trials across different therapeutic areas and sponsors. - Competitive salary, car/travel allowance, and benefits. - Supportive and collaborative team culture. - Health & Wellbeing: Comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues. - Flexibility: Balance your work and personal life with flexible arrangements. - Extra Leave: Generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave. - Charitable Giving & Volunteering: Paid volunteer time to support non-profit organizations that matter to you. - Learning & Development: Access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

• Support the development of drug product formulations from early preclinical enabling studies through clinical supply for First-in-Human (FIH) trials • Contribute hands-on laboratory execution, data analysis, and technical documentation in support of formulation development for oral and/or parenteral dosage forms • Perform hands-on formulation development activities for preclinical and early clinical drug products, including FIH studies • Prepare and evaluate formulations for in vivo (PK, tox) and clinical use • Execute laboratory experiments including formulation preparation, characterization, and stability testing • Maintain accurate and well-documented experimental records in electronic laboratory notebooks (ELNs) • Support scale-up, tech transfer, and manufacturing activities for clinical supplies • Assist in preparation of protocols, reports, and CMC documentation to support regulatory submissions • Collaborate cross-functionally with analytical, DMPK, toxicology, quality, and external partners/CDMOs • Troubleshoot formulation and manufacturing challenges; propose practical solutions • Ensure compliance with internal procedures and applicable GMP/GxP requirements

Role Description CNEE is seeking paid student research interns to join our team. This internship is a unique opportunity for students interested in learning about clean energy policy. The successful applicant will work closely with our Research Manager, CNEE’s expert staff, and other student interns on a variety of projects, including: - Advanced Energy Legislation Tracker (AEL Tracker) - State Policy Opportunity Tracker for Clean Energy (SPOT for Clean Energy) - Clean Energy Legislative Academy (CELA) We welcome successful applicants to work from our offices in Denver, CO. This position is also available for remote work. Essential Job Duties - Analyze energy legislation, manage data, create graphics, perform research, and write-up results to support the AEL Tracker, SPOT for Clean Energy, and other CNEE initiatives. (75%) - Work collaboratively with CNEE team members to develop reports and presentations related to state-level energy legislation and policy. (15%) - Work on short-term research assignments for CNEE staff, which includes creating memoranda on current energy policy developments. (5%) - Attend and contribute to weekly team meetings. (5%) Qualifications - Excellent research, communication, and analytical skills. - Demonstrated policy, science, or technical writing skills. - Demonstrated ability to work effectively under limited direct supervision. - Demonstrated proficiency in the Microsoft Office Suite. - The department cannot sponsor a visa and requires U.S. work authorization. Requirements - Must be eligible to work in the U.S. - Must be willing and/or able to work for CNEE a minimum of 10 hours per week. Benefits - Robust benefits package. - Collaborative atmosphere. - Focus on work-life balance. Company Description Colorado State University is not just a workplace; it’s a thriving community that’s transforming lives and improving the human condition through world-class teaching, research, and service.

Role Description Experienced In-house Clinical Research Associate responsible for site management tasks for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Provide support to Clinical Trial Managers (CTM) and field Clinical Research Associates (CRA) and collaborate with project team members across a variety of roles and departments to ensure timely achievement of site management deliverables per contracted timelines. Provide mentorship and training of in-house team members with Clinical Operations Manager (COM) oversight. What you will do: - Assist with feasibility questionnaires and Confidential Disclosure Agreement (CDA) collection from potential sites, as requested. - Coordinate study material (e.g., Case Report Forms (CRFs), manuals) shipment and receipt by study sites. - Provide applicable updates for site-related documentation for filing in the Trial Master File (TMF) and review collected documents for quality in accordance with Good Documentation Practice (GDP) and Worldwide Clinical Trials Standard Operating Procedures (SOPs) prior to submission to the TMF. - Support field Clinical Research Associates (CRA) with maintenance of the Investigator Site File (ISF) by assisting with Trial Master File (TMF) reconciliation and providing support on TMF Quality Control Checklist (QCCL). - Conduct pre-study, study initiation, interim, remote monitoring, and close-out visits under the guidance of the field CRA or CTM/Project Manager (PM), as applicable. - Discuss and assist field CRA and/or site staff with Investigational Product (IP) inventory, as applicable. - Maintain regular communication with sites per the Clinical Monitoring Plan and Site Management and Monitoring Plan, as applicable. - Complete remote review of electronic data capture (EDC) systems CRFs for completion, logic checks, and compliance with data entry requirements. - Assist sites in resolution of Data Management (DM)-issued EDC queries and vendor-issued queries. - Pull reports from study-specific portals and EDC systems, create or maintain study-specific trackers, and provide information to CTM for distribution to or use by the project team or sponsor. - Provide visit preparation support for field CRAs, including routine summarization and communication of items such as action items, protocol deviations, EDC queries, vendor queries, study supplies, and pending site staff training prior to scheduled onsite visits. - Assist with site staff changes as needed, including Clinical Trial Management System (CTMS) updates, essential and regulatory document collection, and review of site staff training, qualifications, and task delegation. - Assist with vendor access management for site staff (request and revoke access). - Support sites with prescreening, screening, and recruitment. - Assist with subject eligibility review tracking and provide support to the Medical Monitor, as applicable and budgeted. - May serve as the main point of contact for operational aspects for clinical research trials, as applicable. - Provide mentoring and training for In-house Clinical Research Associate I and II. - Attend and present updates during study meetings, if required. - Perform other duties as assigned. Qualifications - Good oral and written communication skills. - Good planning and organizational skills with effective time management. - Good interpersonal skills. - Ability to work in an organized and methodical manner. - Good understanding of clinical research principles and processes. - Good understanding of Food and Drug Administration (FDA) and/or European Union (EU) Directive regulations, International Council for Harmonisation (ICH) guidelines, and local regulatory requirements, with training provided by Worldwide Clinical Trials. - Good understanding of standard operating procedures, with training provided by Worldwide Clinical Trials. - Basic knowledge of Microsoft Office. - Familiarity with Interactive Voice Response System (IVRS) and electronic Case Report Form (eCRF) systems, with training provided by Worldwide Clinical Trials. Requirements - A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science AND a minimum of two years of clinical research experience (e.g., study coordinator, research nurse) OR one year of In-house Clinical Research Associate experience OR other relevant experience. - OR a two-year college curriculum or equivalent education/training AND a minimum of three years of clinical research experience (e.g., study coordinator, research nurse) OR two years of In-house Clinical Research Associate experience OR other relevant experience. - OR other relevant education/training (e.g., Licensed Practical Nurse (LPN) certification and/or relevant work experience) AND a minimum of four years of clinical research experience OR two years of In-house Clinical Research Associate experience. - AND fluent in the local languages of the countries under responsibility and proficient in both spoken and written English. Company Description Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity.