Marisa Sherwin

• Implementation and oversight of hepatology, luminal and inflammatory bowel disease clinical research trials from feasibility to close out
• Study start-up activities including feasibility questionnaire, CDA submissions, Site Selection Visits, regulatory review
• Assign clinical projects, monitor and evaluate project workload
• Act as primary liaison between pharmaceutical sponsors, principal investigators and clinical research staff
• Effectively manage and coordinate simultaneous projects and successfully prioritize multiple tasks to meet timelines
• Act as primary liaison with support services such as: pharmacy, Alberta Precision Labs, endoscopy, clinical investigation unit, diagnostic imaging and Northern Alberta Clinical Trial and Research Center
• Provide regular updates to the Employer’s stakeholders on the progress of transition including any pilot projects and/or roll out within the different units
• Provide guidance and recommendations to Employer stakeholders as required
• Discuss study initiation and progress with investigators and other members of the study team
• Attend Investigator meetings and site initiations visits as required
• Quality Assurance checks on patient source, regulatory documents and other study related materials to ensure compliance for GCP, site policies and SOPs
• REB submissions including ICF creations and facilitating the approval of studies for start-up

HR Aspects

• Hiring and orientation of new staff
• Termination of staff
• Staff contracts updates
• Lead management and staff meetings
• Leading team building events
• Performance evaluations
• Payroll - Approve
• Ensuring staff are fully trained on SOPs and Policies, up to date on licenses, CVs, relevant training
• Completion of regulatory documents including 1572, Note to Files, Delegation Logs, Training Logs in order to keep studies up to date
• Provide leadership, guidance, mentorship and coaching to clinical research staff

Finance Aspects

• Oversight of financial administration including contract and budget negotiations
• Budget development: 1. Create site budget for each research project based on project specific protocol and projected site’s cost to complete the project. 2. Negotiate terms of finance with remote vendors. 3. Management of budget template and updates for current costs and projecting remote effects of economic fluctuation on budget
• Reporting, invoicing and account reconciliation
• monitor financial viability of GILDR and ongoing trials
• Accounts Payable
• Accounts Receivable
• Reconcile monthly General Ledger for multiple Alberta Health Services research accounts
• Account Closures - Manage the timely closure of research accounts

Regulatory/Quality Assurance Aspects

• Regular review of patient source documents to ensure compliance with site’s SOPs, policies and Good Clinical Practice (GCP)
• Regular review of regulatory documents and records such as 1572, QIU, COI, Note to Files to ensure accuracy and compliance with local authorities including IRB board.

• My role entailed oversight of all clinical research accounts and HR tasks that included staff contracts and internal tracking of vacation, sick and pension equivalent accruals and payout.
• Reporting, invoicing and account reconciliation for multiple research accounts
• Accounts Payable - Verify invoices and create payment requisitions
• Accounts Receivable - Create/monitor invoices to internal/external customers based on contracts and budgets. Verify incoming payments, confirm accounts and create memo for deposits
• Account tracking - report to Investigators their multiple research account balances, anticipate revenue and expenses, advise Management Board on accounts which require attention
• Reconcile monthly General Ledgers for multiple research accounts
  Account Closures
• Contract and budget negotiations to create budgets per project based on study and site’s needs

HR Aspects

• Position Postings, interviews, reference checks and orientation of new staff
• Termination of staff
• Payroll - time entry
• Tracking timesheets
• Process and manage employee benefits and expense reimbursements
  Update SOPs and Policies
• Assist with Regulatory Documents including submissions and completion of 1572, QIU forms

I worked as a casual assistant within the benefits department to assist them with various tasks:

• Assembling benefits packages to send out to staff
• Phone calls to advise staff their benefits packages were being sent out
• Confirming receipt of benefits packages
• Collecting signatures on documents
• Filing documents
• Copying documents
• Any additional tasks required to assist the Benefits team with their work.