Available Positions

Clinical Operations Leader at Pharmaceutical Company in Durham, North Carolina, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • Durham, North Carolina, United States
  • 10/17/20

Job ID: 66003

Job Description

Job Description:

The Clinical Operations Lead (COL) is responsible for management of day to day aspects of investigator site and Clinical Research Associate (CRA) activities for the assigned clinical trial(s) and has primary responsibility for all clinical deliverables.  The COL, in concert with the Project Manager (PM), is accountable for the quality, timely, and cost-effective completion of the Sponsor’s study.  The COL will conduct assigned study related clinical services, may monitor a limited number of sites, and assist in the management of CRAs for either domestic or globally run clinical trials.  In addition, the COL may manage projects depending on the required level of experience and capabilities.

 

The COL executes Clinical Operations functions in accordance with Good Clinical Practices (GCP), Corporate Policy, Standard Operating Procedures (SOPs), and applicable regulations.

 

Duties:

  • In a matrix reporting structure, train, manage, and assess CRAs in the conduct of clinical trials, including site management and monitoring responsibilities.
  • Arrange and perform periodic quality control visits to research sites according to project management and clinical monitoring plans.
  • Review and approve CRA site visit reports to ensure completeness and accuracy. 
  • Ensure CRA site visit scheduling requests, site visit reports, and follow up correspondence are timely and in accordance with company standard operating procedures.
  • Act as a liaison between CRA Team, Project Management, Sponsor, and the Principal Investigatorproviding accurate information and maintaining a professional working relationship with all team members.
  • Assist in the identification and recruitment of potential investigators and study sites. Verify site qualifications and capabilities to conduct clinical studies.
  • Convey site responsibilities and obligations to the investigative study sites through the conduct of initiation visits.
  • Participate and attend investigator meetings for assigned clinical trials.
  • Work with relevant project team members to prepare study forms and to provide tracking reports on enrollment, CRF submission, study start up, and study completion information.
  • Document accountability, stability, and storage conditions of clinical supplies and materials.
  • Review all site and sponsor communications, including telephone contacts and trip reports.
  • When monitoring/co-monitoring, submit timely and accurate site visit and status reports as required.
  • Conduct a close-out inventory of clinical supplies and coordinate the return shipment of unused materials per the Sponsor’s instructions.
  • Work in conjunction with the assigned Project Manager (SPM or PM) to coordinate clinical study organization, implementation, and management with the Sponsor management personnel.
  • Assist the PM in writing laboratory specifications per study protocol and coordinating with lab vendors as necessary.
  • Review and approve all Company and Federal Drug Administration (FDA) essential regulatory documents required for implementationmonitoring, and evaluation of clinical trials, as well as design protocol-specific manuals, plans, and documents as needed. 
  • Manage the identification and recruiting of investigator physicians and study sites by verification of qualifications and capabilities for successfully conducting clinical studies.
  • Work with PM to assist with the management and evaluation of contracted services, such as central lab, IVRS, central IRB, drug distribution vendors, meeting planning services, etc.
  • Conduct pre-study site visits, review the accuracy of study initiation documents as well as coordinate study drug supply, laboratory supplies, and file notebooks.
  • Work with relevant project team members, provide and Sponsor management projections on enrollment, CRF submission, study completion and other information as requested.
  • Work with the PM to understand the fiscal performance of the study through negotiation of investigator budgets and monitor payments to investigators and contracted services (if applicable), while maintaining close control over Research study costs.
  • Document accountability, stability, and storage conditions of clinical supplieand materials.
  • Assist Quality Assurance (QA) by performing quality control audit procedures, including Research and Investigator study files, as well as clinical review of collected data and clinical forms.
  • Provide clinical support for Data Management by resolving data queries and clarifying data entries as requested.
  • Work with the assigned PM to generate timely and accurate project status reports as required by the Sponsor and Research management and respond promptly to managerial questions associated with the clinical study.
  • Provide field and/or in-house training as part of career development for CRAs, assist in training progress assessment, and facilitate career development training for direct report employees.
  • Maintain compliance with all policies, procedures of the company, including security and safety.
  • Respond to employees in a professional, timely and thorough manner using company resources as necessary.
  • Routinely stay abreast of GCP, updated guidance and regulations from FDA as it relates to clinical research, as well as current clinical related developments in the assigned therapeutic areas.
  • Other related projects and activities as assigned.   

Qualifications

  • Bachelor’s degree (B.A./B.S.) in science or RN with clinically related experience. Data management background is a plus.
  • 4 years of clinical trial monitoring experience (Phase 1-3), along with 1-2 years of COL/APM experience.  Skilled in EDC is also required. 
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • The COL can expect to travel 10% to 30% which will include on-site monitoring, co-monitoring, on-site audits, and CRA training/qualification visits.
  • Certification with a known industry professional organization is desired. 

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