SRI International Hiring for Director of Clinical Operations Primarily Early S at Plymouth, Michigan Full Time

Director of Clinical Operations – Primarily Early Stage Clinical Trials, Specialized Research
Job Locations

US-MI-Plymouth

ID 
2023-5528  

Category 
Biosciences  

Position Type 
Full-Time  

Worker Type 
On-Site
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.
SRI Biosciences is proud to offer clinical trial services for biotechnology and device companies, university investigators, government agencies and other clients and partners.  SRI Biosciences’ leadership in drug discovery and translational development offers expanded clinical trial and strategic development services.
SRI’s Clinical Trial Unit (CTU) leverages core competencies and relationships to provide agile, top-tier R&D with the capacity to carry programs from concept to clinic.  In addition to the execution of clinical trials, SRI will also provide early strategic guidance in the refinement of efficient, scientifically sound product development plans leading to a future drug or device that addresses a well-defined unmet medical need.
Our state-of-the-art CTU facility with 13 beds and 3 infusion recliners, is located at the Michigan Life Science and Innovation Center in Plymouth, MI, central to academic medical centers in Ann Arbor, Detroit and Royal Oak and within 20 minutes of the Detroit International Airport.

Responsibilities

Responsibilities:
The SRI Biosciences Division is looking for a Director of Clinical Operations, who can manage the following:
Manage the ongoing day to day responsibilities of the clinical trials unit facility and studies, including but not limited to:
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, and pharmacy/lab technicians as required; a number of staff will be temporary hourly employees
Collaborate with the VP of Translational Development to solicit and maintain adequate number of qualified Principal Investigators (PIs) in specific medical disciplines to conduct studies
Understand 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 Good Clinical Practice guidelines
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
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
Maintain regular communication regarding billing and oversight in