Participate in clinical research teams to ensure effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support
Develop, review and update study-related training materials and documents including: site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods
Communicate scientific rationale for assigned studies to team members and clinical sites
Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
Create/edit, distribute and collect site feasibility questionnaires
Oversee and support collection of essential documents during study start-up
Collect study and site metrics and maintain study trackers
Participate in case report form (CRF) data review and review of source documents, work with sites to resolve data queries as needed
Communicate regularly with field and in-house Clinical Research Associates (CRAs) to provide information before and after site visits
Partner with field CRAs to resolve issues identified during site visits
Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) and resolve IP temperature monitoring excursions and train or assist sites with corrective actions
Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
Clinical specimen log review and coordinating shipment of specimens to the sponsor or contracted vendor
Conduct remote monitoring tasks including reconciliation of site investigational product accountability
Provide mentorship and training to newly hired research staff
Perform other duties as assigned
Requirements
Bachelor’s degree in a clinical research, science, or health-related field with 6 years of experience in a clinical research setting; or a high school diploma with 8 years of experience in a clinical research setting
Minimum of 2 years’ experience as a Clinical Research Associate II or higher required
Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
Excellent written/oral communication skills
Strong organizational and multi-tasking skills
Understand the job-specific system, processes as defined by the company’s SOPs, and adhere to the requirements listed in those documents
Maintain corporate confidentiality at all times
Ability to set priorities and independent decision making
Ability to work independently as well as in teams
Ability to discover issues, provides solutions and provides guidance to in-house team on how to address issues
Outgoing and confident demeanor
Independent thinker and persuasive communicator
Detail oriented, with solid organization and time management skills
Completes projects with reliability and minimal guidance
Knowledge of drug development process
Computer literacy: EDC, eTMF, CTMS, etc.
Working knowledge of ICH E6, and the Code of Federal Regulations
Must be able to travel up to 75% of the time based on study requirements
Remote with ability to work flexible hours for various time zones
Benefits
Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
Discretionary bonus and equity award eligibility
Professional development opportunities
Tools and resources to optimize Health and Wellness
Policy and Research Analyst contributing to government initiatives impacting court services in Alberta. Conducting research and providing insights to senior management to support decision - making processes.
Postdoctoral Research Associate conducting experimental mechanistic analysis at University of Edinburgh. Joining a collaborative team focused on research into organoboron species.
Research Associate role assisting in imaging operations across multi - center stroke studies at UC College of Medicine. Collaborating on high - quality neuroimaging data collection and supporting scientific discovery.
Analyst role within Metals & Mining Research team, conducting analysis and supporting client engagements at Wood Mackenzie. Requires expertise in relevant commodities and strong analytical skills.
Senior Research Analyst at JM Search executing targeted search strategies and conducting market research. Collaborating with recruiters to identify and source high - impact candidates across industries.
Mid - Level Insight Research Analyst leading impactful research projects at USAA. Collaborating with teams to provide data - driven recommendations for member - focused strategy.
Manager Field Research Specialist leading a high - performing field research team at Johnson & Johnson. Focused on clinical trial excellence and partnership across the U.S.
Claims Research Analyst responsible for reviewing and processing claims for provider agencies at Alliance Health. Providing training and support to stakeholders and managing technical issues.
Property Tax Analyst responsible for managing property tax compliance and conducting research for commercial real estate clients. Collaborating with team members while ensuring accuracy and attention to detail.
CRA role overseeing clinical trial execution, ensuring compliance and communication between sponsors and sites. Focused on site performance and data accuracy while based in Brisbane or Perth.