Closing date: Will remain open until suitable candidate found

Salary: Commensurate with experience

Benefits: Health/dental plan, employee & family assistance program, retirement plan, perks

Start Date: Jun/Jul 2024

Primesite Research Solutions is an Integrative Research Organization and Site Network based out of Western Canada. We conduct phase I, II, III, IV clinical trials in various clinical areas at local hospitals and clinics. We are seeking a research assistant to join our growing site network. This position requires a self-motivated, organized, and accountable individual with strong attention to detail. The applicant must have the ability to prioritize and multi-task in a complex rapidly changing environment and must be able to promote teamwork, collaboration, and problem-solving skills. In this position the research assistant will work under the supervision of the research coordinators and research manager to fulfill clinical trials related responsibilities and ensure that each study progresses efficiently. The research assistant will also be responsible for data entry and management of selected patient registries. This position requires frequent contact with physicians, other staff, study participants, biopharma companies and regulatory agencies, and has significant potential for advancement.

Key Responsibilities:

• Adhere to multiple research protocols, confidentiality, ICH, GCP & NIH guidelines
• Prepare REB submissions and other regulatory documents required for study initiation
• Perform data entry for clinical trials and registries
• Prepare for and participate in monitoring visits and conference calls
• Develop study files in accordance with various protocols
• Provide administrative support including filing, directing phone calls, updating tracking logs and maintaining trial regulatory documents
• Organize and maintain project/task management system and clinical trials management system (CTMS)
• Organize, prioritize and respond appropriately to incoming correspondence
• Maintain optimal office systems, processes and equipment
  
• Coordinate with various departments and correspond with study sponsors and regulatory agencies
• Communicate study procedures and provide ongoing support to staff
• Screen hospital charts for potential study participants and be able to discuss eligibility with coordinators and physicians
• Organize ongoing patient follow up and study visits
• Perform study procedures (including collection of vital signs, blood, ECGs etc) as requested
• Comfortable handling and transporting blood, marrow and other lab samples
• Travel between hospitals for various tasks
  
• Work effectively with study research coordinators and manager to ensure open communication and efficient prioritization of all assigned responsibilities

Required Skills for Success:

• Undergraduate degree required, patient interaction and clinical trials experience are preferred (other education with clinical research experience will be considered)
• 2-3 years of experience in working with clinical trials/research studies
• Must be comfortable interacting directly with patients
• Working knowledge of Microsoft Office software (Word and Excel) and Google Apps (Docs and Sheets) required
• Tech savvy, willingness to learn and adapt to new technologies, and ability to proficiently use required technologies and applications: online software including for meetings, training, timesheets, project/task management, document management and CTMS
• Excellent organizational, communication (oral and written), problem solving and interpersonal skills in dealing with co-workers, clinicians and study participants
• Demonstrated ability to take initiative and work in a team environment as well as independently with minimal supervision in a fast-paced environment
• Ability to be flexible, assist on multiple projects and successfully prioritize multiple responsibilities to meet deadlines
  
• Work in a professional and ethical manner in accordance with internal policies and procedures, and GCP and ICH guidelines
• Self-directed, proactive attitude, highly self-motivated and enthusiastic
• Accountable with strong attention to detail and honest in the performance of all responsibilities
• Willingness to further professional knowledge by reading journals/books, attending educational sessions, completing training programs as necessary
  
• Own transportation and valid driver's license are beneficial as travel to other sites may be necessary

If you are selected for the next step in the interview process, you will be asked to submit a short one-way video application.