Clinical Research Site Director

Clinical Research Site Director Healthcare Business Associates Boise, ID Job Details Full-time 3 hours ago Benefits Dental insurance Vision insurance Qualifications Vendor relationship building Statistical software Teamwork HIPAA Patient interaction Health information management

Full Job Description Site Director Responsibilities:

Advertising/Marketing/Recruitment plans & management:

• Decide on recruitment strategies
• Communicate and coordinate with Launch myStudy regarding advertising needs/plans/budgets.
• Link local advertising campaigns within RealTime once campaign live Manage recruiters/

Recruitment:

• Communicate feedback and provide assistance to recruiters
• Help with scheduling and RealTime questions and training o Send recruiters incl/excl and prohibited meds list for each new study and ensure fully trained (ensure recruiters know where to access in SharePoint)
• Call Log management o Oversight of received call logs and recruitment results o RealTime database clean up based on dormant/incorrect/withdrawn profiles

RealTime System Administration:

• Building of studies within RealTime (Protocol/Main Study Information page, Accounting Summary Page
• financials/contract information, Recruitment Campaign Manager
• advertising budget information, Phone Screens, Study Visit Template
• visits, procedures, cost, revenue)
• Managing upkeep of Entities, Tables, Reports, Configuration
• Corresponding with RealTime for problem solving and new information or updates to our system Pipeline
• team effort with

HBCA:

• Communicate with HCBA regarding our level of interest in potential studies, completion of feasibilities or other requests that may come to move things forward
• Attend twice monthly meetings with HCBA
• Maintain the study board within Asana as updates occur
• Feasibility completion and submission if outside of

HCBA Invoicing/Payments:

• Input invoice-able items into RealTime as they occur. (List compiled as a running list monthly by Regulatory Specialist)
• Submit invoices as appropriate (via email or applicable portals)
• Track down payments
• Apply payments within RealTime and ensure correct payment
• SF adjustments within RealTime Incoming study Contract negotiation/execution process support:
• Build budget into RealTime once finalized as noted above

GDUFA/DUNS

submissions and renewals:

• Contact Paul once a year for GDUFA renewals
• Complete process of any new submissions that need to be done Visit QC in

RT:

• Ensure visits have been completed in RealTime correctly
• Monitor overdue and unscheduled visits within RealTime Create and edit source documents as needed:
• This in the event of a rapid startup where the lead study coordinator is not able to perform this General assistance where additional help is needed Writing/review of phone screens:
• Ensure phone screens are written with detail and quality prior to initial IRB submission of the regulatory packet
• Request regulatory submit for sponsor/IRB approval
• Build into RT once IRB approval is received Participation in SIVs for study overview, expectations, timeline, etc. Contractor pay (Providers and Vendors):
• Track investigator time and pay monthly
• Track vendor usage and pay HR/ Insurance admin:
• Submit insurance applications for new employees to Sarah Taylor (follow up to ensure submitted and coverage is confirmed as active as needed)
• New employee onboarding
• Track and manage Employee sick time and PTO

Payroll:

pull report for bookkeeper and QC paystub printout before bookkeeper finalizes

SIMPLE IRA

track eligibility, offer once employee is eligible, share required notices for plan, ensure correct employee contribution is being made

• Annual review of plans with Sarah Taylor to ensure best and most cost effective plans for health, dental, and vision are selected for following year Meeting planning:
• Boise meeting: monthly Review/signoff sponsor (monitor follow-up) letters: CRA contact:
• Visit with CRAs when they are onsite regarding study progress and to ensure all needs and requirements being met
• During monitoring visits, assist coordinators with query resolution if needed to ensure completed prior to CRA site departure wherever possible CAPA management:
• Confirm with Dr. Brock when a CAPA would be necessary versus a protocol deviation or protocol retraining
• Let responsible party know to complete a CAPA and ensure completion

Ordering:

• Office and medical supply ordering
• Crash cart meds expiration monitoring Setup and attend PSVs Credit card statements:
• Print from bank portal and give to bookkeeper if mailed copy not received
• Track down receipts for any charges that have not been given to bookkeeper already Stipend requests:
• Give to bookkeeper and redispense to coordinators, track down additional info if needed Manage vendors and

Contractors:

• Setup and manage relationships with outside study vendors (MRI, LP, PET, etc.)
• Contact non-study vendors as needed (IT, Peak Alarm, Net2Phone)

TSheets:

• Make adjustments for staff as needed/requested
• Pull reports as needed SOP Updates and management Source document QC per FDA inspection

Work Location:

In person