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Source Worksheet Development Assistant
2 weeks ago
Based in Waterloo, Ontario, Canada Probity Medical Research (PMR) is an administrative support company that partners with clinical research sites and pharmaceutical companies to provide essential administrative services for clinical research trials.
As a rapidly growing company, we are committed to advancing clinical research through exceptional service. PMR is an equal-opportunity employer, offering competitive wages, healthcare benefits, and an inclusive work environment.
PMR is looking for a Source Worksheet Development Assistant, responsible for preparing data capture tools and performing administrative tasks for clinical trials, which requires a strong discipline in regulatory knowledge and compliance.
We thank all applicants for their interest, however, only those selected for further consideration will be contacted.
Job Responsibilities
Source Worksheet Preparation
- Prepare data capture tools including various source worksheets, schedules, logs, and other forms as required to facilitate accurate and complete data capture according to the study protocol.
- Involves the meticulous review of study protocols and related documents to ensure sites capture and perform all necessary assessments for subject visits, including consent documentation and clinical assessments.
- Review all available study documentation to ensure the accuracy and completeness of the data capture tools prepared, to prevent protocol deviations at sites. This includes but is not limited to the study protocol, CRF, CRF Completion Guidelines, manuals (laboratory, pharmacy, photography, etc.), sponsor source worksheets/tools, and patient materials.
- Identify and address potential issues such as missing details or contradictory instructions in the provided study documentation to ensure that clear and correct instructions are provided in data capture tools.
- Update and create new source worksheets as needed following protocol amendments and other updated documents (e.g., CRF, sponsor source worksheets, patient materials) to ensure continued accurate and complete data capture.
- Regularly monitor recruitment at PMR-affiliated sites to determine if/when additional source worksheets will be required.
- Meet deadlines for providing data capture tools to PMR-affiliated sites as per Source Worksheet Development Work Instructions, to avoid delays in subject enrollment and scheduled study visits.
Internal Communication
- Communicate (oral and written) to confirm understanding of team processes, tasks assigned, and feedback received.
- At team meetings, share lessons learned during assigned duties to facilitate the growth and experience of the team.
- Review and provide feedback on Work Instructions, training materials, tools, and other documentation.
- Obtain required information on study timelines to ensure appropriate deadlines are set as per Work Instructions, obtain required study documentation, and request clarification from sponsors and sites as needed to prepare accurate and complete data capture tools.
- Inform of potential errors in documents that require ethics approval including but not limited to Informed Consent Forms, to ensure that sites receive accurate study documents.
External Communication
- Contact sponsors and sites directly via email or phone to expedite the resolution of outstanding queries.
Online Platform Management
- Work within PMR's online platform (Portico), performing daily tasks including:
- Create and maintain all data capture tools directly in Portico to ensure seamless access by other PMR team members in the event of an absence or other need for assistance.
- Upon request, upload sponsor documents to the Source Worksheets library in Portico to maintain complete study files.
- Upload all email correspondence to Portico as per Source Worksheet Development Work Instructions.
- Maintain both study and site Source Worksheet libraries, uploading and sending documentation to sites as required.
- Create announcements and tasks in Portico to communicate to sites when new/updated documents are available in their Source Worksheets library.
Organization / Task Coordination
- Maintain the Source Worksheet Task Tracker as per Source Worksheet Development Work Instructions, to facilitate fair workload distribution and collaboration among team members and allow for more efficient coverage of planned and unplanned absences.
- Provide out of office coverage for other Source Worksheet Development team members.
Skills
- Attention to Detail
- Excellent Communication Skills (oral and written)
- Strong Organizational, Prioritization, and Time Management Skills
- Ability to work independently and be a team player
- Adaptable/Flexible
- Collaborative
- Solid Problem-Solving Skills
- Creative and Innovative Thinking
- Decision Making
Qualifications
- A bachelor's degree or college diploma in Computer Science, Health and Life Science, General Science Programs, or a related field (preferred), or
- 1-2 years of similar work experience an asset.
- Science or clinical trial experience is preferred but not mandatory.
- Intermediate knowledge of Microsoft Office Suite (particularly Word and Excel)
- Self-starter with positive attitude, ability to take initiative and work with minimal supervision.
- Proven capability to manage and successfully complete multiple concurrent projects.
- High level of critical and logical thinking, analysis, and reasoning.
- Enjoys administrative work; consistently at a desk using a computer to review multiple documentation platforms and resources to prepare and complete necessary work.
Working Environment
Each department has their own training requirements for in-office, hybrid or remote. Generally, most positions will be eligible for a hybrid training schedule or remote. Home office setup requirements include a secure and reliable internet connection, an additional monitor, ergonomic workspace and privacy. This is an option, as staff can choose to work full-time from our office.
- Manual dexterity is required to use a computers and peripherals
Monday - Friday 9:00AM-5:00PM
40
