Sr. Clinical Research Site Director

Description

The Senior Clinical Research Site Director will be responsible for the supervision and operation of Elligo owned research site(s). The role ensures the effective end-to-end planning, execution and close-out of clinical research trials as well as the selection of clinical trials at Elligo owned site(s). They will work with key functional and strategic partners externally to develop collaborative relationships with local practices/physicians and other community sources for potential study participants, and across Elligo departments to drive study pipeline and study enrollment/retention.

II. SUPERVISORY RESPONSIBLITIES

• Clinical Research Coordinators
• Research Assistants
• Lab Technicians
• Phlebotomist
• Contract staff (Pharmacist)
• Other Direct Reports TBD
  
  

Iii. Essential Duties

• Manage overall operation of the site(s) including project plans, and resources to ensure compliance with the protocol and contracts.
• Ensure site staff and direct reports are appropriately trained, mentored, and supported to enable their success.
• Provide oversight and coordination in evaluating and approving clinical trials to be conducted at site(s)
• Maintain an overview of clinical trial operational status or risks and proactively communicate the progress, issues, or protocol revisions that may impact timelines and costs.
• Design, execute and oversee processes to ensure the appropriate conduct of research, including:
• Identification and screening of patient per study consistent with protocol requirements
• Consenting subjects into a study
• Utilization of appropriate, effective patient and community outreach tactics to drive interest and enrollment per trial, in partnership with Elligo’s Patient Engagement function
• Tracking subjects and maintaining all records according to study protocol and regulations
• Effectively coordinate with investigators from initial study identification through study close-out on all studies.
• Work closely with Finance to ensure, billing and accounts receivable and payable are accurate and timely on each trial
• Conduct study closeout in an organized and detailed way to ensure it is consistent with Elligo and/or sponsor expectations.
• Identify risk mitigation strategies and develop contingency plans to ensure the quality and integrity of each study.
• Accountable for ensuring departmental financial and strategic goals are achieved on time. Includes risk identification and mitigation and communication with CMO.
• Work closely with the Health Care Partnerships to assess operational feasibility for new business opportunities, collaborative agreements with local practices/physicians and contribute to strategic initiatives for the future growth of the site.
• Identify and pursue opportunities to increase community awareness and engagement to facilitate participant access the clinical trials at the site(s)
• Assist with the hiring and oversight of contract personnel, vendors and equipment needed for study conduct
• Oversee the implementation of new company processes.
• Maintain confidentiality, embrace diversity, facilitate change, and foster an inclusive workplace where diversity and individual differences are valued and leveraged to achieve Elligo’s mission.
• Ensure operational excellence and integrity through adherence to Elligo policies and procedures, client requirements, GCP, ICH, FDA, EMA, and all relevant international regulatory requirements
• Other Duties as assigned
  
  

Requirements

• BS/BA in Life Science or related discipline or equivalent work experience
• Minimum of 8+ years of clinical research site experience, including at least 5 years in a managerial capacity
• Previous nursing experience in a clinical setting a plus
• Demonstrated ability in positive relationship building, with strong verbal and written skills required.
• Strong interpersonal skills with attention to detail
• Demonstrated ability to work collaboratively with cross functional departments/groups
• Excellent verbal, written and presentation skills
• Strong organization/prioritization skills for the management of multiple concurrent projects and tasks
• Executive presence and professional demeanor appropriate for working effectively with physician and administrative leaders of collaborating practices
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial management systems.
• Ability to travel fulfill job requirements, as required (locally and occasionally further)
• Ability to act and operate independently with minimal daily direction from manager to accomplish objectives