SRI International

Director of Clinical Operations

Job Locations US-MI-Plymouth
ID
2021-4881
Category
Biosciences
Position Type
Full-Time
Worker Type
Fully Remote

Overview

SRI International, an over 75-year strong pioneering research institute, has a rich history supporting government and industry. Our innovations have created new industries, billions of dollars in market value and lasting benefits to society. SRI is organized around broad disciplines and capabilities, with research and development divisions and labs to groups who excel at identifying new opportunities, developing products and creating custom solutions. Our organization is driven by impact - delivering unique solutions for the world's important challenges and transforming ideas into reality for clients and partners.

Responsibilities

The SRI Biosciences Division is looking for an Director of Clinical Operations, who can manage the following:

  • Solicit/hire qualified site staff
  • Define and communicate role-specific responsibilities and performance standards
  • Assess performance for full time and PRN staff and provide feedback at regular intervals (at least annually)
  • Responsible for maintaining adequate, qualified staffing of clinical research staff including but not limited to nurses, research coordinators/assistants, pharmacists, andpharmacy/lab technicians as required
  • Collaborate with the VP of Translational Development to solicit and maintain adequate number of qualified Principal Investigators (PIs) with appropriate therapeutic experience to conduct studies
  • Escalation point for any issues related to clinic spaceLiaise with SRI leadership, study sponsors, stakeholders, and/or other applicable parties regarding clinic space or supplies as neededUnderstand applicable research study protocols and sponsor expectations
  • High level oversight of study performance regarding actual enrollment VS sponsor expectations, quality of study conduct per protocol and GCP
  • Schedule and host regular internal meetings with study site staff and other stakeholders as needed
  • Produce documentation of internal meetings and distribute to attendees and/or stakeholders
  • Collaborate with VP, PIs, sponsors, and site staff where applicable to assess study progress, talk through issues, and provide guidance on issue mitigation as applicable
  • Review financial data at regular intervals and confirm financial data accuracy during dashboard review and other meetings as applicable
  • Provide oversight of billing and invoicing process, to facilitate timely invoicing of billable milestones, enrollments, and other applicable tasks
  • Provide support as needed to ensure adequate understanding of billing and invoicing process at site and address sponsor facing questions/issues as needed (escalation point)
  • Communicate with relevant clinical study teams to understand issues related to enrollment and/or milestone misses negatively impacting ability to recognize revenue and implement applicable mitigation plans
  • Develop and maintain understanding of current business pipeline in terms of lead generation, business wins & loses
  • Work with Contracts, Legal, and Business Office as appropriate for various agreements including but not limited to CDAs and CTAs
  • Manage contract cycle times and perform timely follow-up on status of all contracts until fully executed
  • Manage contract negotiations; maintain ongoing dialogue with site's legal representatives and sponsor(s) as needed
  • Responsible for clinical study budget negotiations and working with Business Office for final SRI budget approval
  • Collaborate with ClinEdge to identify viable study opportunities and assess protocol feasibility
  • Leverage existing systems and data repositories to understand clinical research landscape, trends in Therapeutic Areas, and opportunities for business development
  • Communicate regularly  with larger operations team regarding key business issues and effectiveness of study bids/execution/strategies

Qualifications

  • Minimum of 5-10 years clinical trial site management experience (Phase 1-4).
  • Appropriate clinical experienceBachelor’s or Master’s degree in appropriate field.
  • Prefer business experience in conjunction with site management experience and successful track record of bringing in and successfully completing clinical trials.

 

The salary range for Colorado residents would be $92,192 - $152,690.Salary ranges for this role will vary and are based on several factors, including geographic location, market competitiveness and equity amongst internal employees in similar roles.

 

SRI has a competitive benefits package, to view details please go to https://www.sri.com/resources/benefits/

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