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Manager-Clinical Research

University of Utah


Location:
Salt Lake City, Utah
Date:
03/27/2018
2018-03-272018-04-26
Categories:
  • Clinical Operations
University of Utah
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  • Research Salary

Job Details

The Huntsman Cancer Institute Clinical Trials office is hiring a Manager of Clinical Research responsible for direct oversight of disease specific Clinical Research Coordinator (CRC) and Research Data Coordination (RDC) teams. The position will be responsible for management of team functions as a support to Principal Investigators conducting clinical research. Under minimal supervision, the position is responsible for planning, organizing, directing and overseeing all aspects of the team’s daily clinical research functions, administration needs, human resource and financial management operations pertaining to areas including (but not limited to) clinical data, protocol compliance, standardization of processes, monitoring/oversight of clinical trial operations, development and completion of all aspects of clinical studies as it relates to coordination and data completion requirements. Acts as a catalyst between the department and its customers (PIs) and staff to ensure continuity and quality of service and patient care.

Responsibilities

Applicants must demonstrate the potential ability to perform essential job functions. 
1. Supports Principal Investigators (PI) and study management staff with patient screening/enrollment, eligibility review, data submission, and overall maintenance of new and ongoing clinical trials.
2. Ensures study management staff are providing quality source documents and data to sponsors, while ensuring protocol compliance is maintained within regulatory guidelines and standards.
3. Routinely monitor and ensure compliance with eligibility, protocol requirements, data submission completion while monitoring delinquency rates, outstanding query resolutions 
4. Manage standing team meetings to discuss issues related to the CRC/RDC team and clinical trial needs.
5. Ensure monitoring/auditing reports and outstanding issues with staff are identified, addressed, and resolved in appropriate timeframe while providing direction and oversight.
6. Provides direct personnel management and supervision, while mentoring and training new or junior research staff and providing adequate team coverage plans.
7. Contribute to developing educational materials on coordination and data completion processes and requirements for the teams, as well as evaluation and education tools to assess staff competency.
8. Coordinate with MDG and PIs to provide information on available or competing protocols, workload resourcing for team while providing primary point of contact support for completion of start-up activities (i.e., initiating CDA, Feasibility, MDG scoring and navigation of review committees required for activation, etc.).
9. Prepare clinical research reports for PIs, MDGs, HCI Leadership and sponsors.
10. Participate in CTO Leadership Meetings and ad hoc CTO Working Groups while working closely and collaboratively with fellow CTO Program Managers and Director. 
11. Provides transparent clear directives and constructive, professional communication with fellow Program Managers to promote uniformity across MDGs and within the CTO.
12. Actively attend and participate in representation of the Clinical Trials Office at MDG and RIP meetings for primary teams and as needed for other Clinical Program Managers.
13. Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs)
14. Oversee and ensure completeness in appropriate AE and SAE reporting requirements as well as Deviation reporting to sponsors and the IRB.
15. Facilitate cooperative and collaborative institutional relationships.
16. Ensures PI and MDG satisfaction by analyzing complaints, concerns and suggestions and providing appropriate follow-through.
17. OTHER: Assume responsibility for additional assignments as directed by the CTO Director of Operations.
Disclaimer
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted
as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Minimum Qualifications

Requires Bachelor’s degree in a related area or equivalency (2 years related work experience may be substituted for 1 year of education). Four to six years of progressively more responsible management experience. Background knowledge of hiring department’s area of specialization in order to analyze, plan and draw conclusions for recommendations to superiors. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop subordinates and to ensure the smooth operation of department. Master’s degree in a related area may be preferred.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

Bachelor’s degree in a related area of assignment or equivalency and 4 – 6 years of progressively more responsible management experience. 5 years of clinical research experience is required. 
Background knowledge of assigned department’s area of specialization in order to analyze, plan, train and draw conclusions for recommendations to Clinical Trial Directors. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop subordinates and to ensure the smooth operation of department. 
Completion of provided supervisory/management training within one year of employment may be required.
Successful candidates will have: 

  • Progressive leadership experience preferably in the clinical research industry
  • Advanced knowledge and understanding of regulatory guidelines related to human subject research protections in clinical trial investigations
  • Clinical Trial Management Software experience (i.e., OnCore, Velos)
  • Ability to assess functional processes, workflow and develop improvements for efficiency and quality output.
  • Advanced knowledge of industry standards related to clinical trial coordinator functions and study data management activities; (i.e., complex trial designs, data standards, data reviews, etc.).
  • Demonstrated ability to positively influence others in a team environment
  • Proactive and critical evaluation of multiple aspects of clinical trial execution to ensure timely completion and quality.


Problem Solving
The incumbent decides how to best accomplish the daily requirements of various clinical trial requirements, prioritizes and delegates workload and establishes systems needed to achieve specific team and department goals. Efforts of multiple departments or disciplines (i.e., Regulatory, Finance, and Specimen Processing) must be coordinated to ensure effective follow through and compliance of all involved. 
The incumbent is expected to closely monitor studies in which experimental equipment and drugs are utilized. Federal regulations mandate the regulatory requirements for use of investigational new drugs or devices and the subjects participating in research studies often have no other option for recovery. Analysis on critical research studies is required in order to maintain accurate patient and data compliance with all aspect of the research study in accordance with federal regulations.
The incumbent utilizes federal and institutional guidelines and requirements to ensure compliant execution of clinical trial activities. This position negotiates and communicates extensively with other Clinical Trials Office Managers and the University human subject research protection committees and sponsors to ensure full compliance.
The incumbent is responsible to organize coverage when not present to ensure clinical trial requirements are followed.

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