Job Description

Job Title: Research Operations Coord
Job ID: 61440643
Status: Full-Time
Regular/Temporary: Regular
Hours:
Shift: Day Job
Facility: Magee-Womens Hospital of UPMC
Department: 8961 MWRI Erie
Location: 118 East 2nd St, Erie PA 16507

Description

Magee-Womens Research Institute, Erie, is a new initiative to the Erie Community. It will bring basic clinical research along with clinical trials to the community, with the purpose to improve the quality and cost of healthcare. It will be a satellite of MWRI Pittsburgh and will host protocols ongoing and initiated in Pittsburgh, as well as newly established protocols developed locally and those established in collaboration with PSU Behrend. 

This position is grant funded. 

Purpose:

Position provides administrative support to leadership for the overall development, implementation, and continued evaluation of the overall conduct of the research systems. Position will work in conjunction with the leadership in order to maintain quality clinical research practices by ensuring administrative compliance to ethical, legal, and regulatory standards through appropriate leadership and utilization of personnel and fiscal resources for clinical trials. This includes visionary leadership, knowledge of present and future research regulations and trends, strategic bench markings and innovative interventions.

Responsibilities:
  • Assist in development of educational programs within the system and community (i.e., prevention and control programs, symptoms and pain management).
  • Responsible for content development and delivery of departmental new hire orientation.
  • Assist leadership with the development, implementation, and evaluation of all systems to conduct interdisciplinary clinical research.
  • Responsible for conducting needs analysis as well as designing, developing, implementing and evaluating education and training programs for the Department, in order to support employee understanding and adherence to established SOPs and governing regulatory departments.
  • Assist leadership with preparing budgets and contracts based upon analysis of goals and established standards.
  • Facilitate staff development in specialized areas of gynecological diseases and disorders to facilitate protocol implementation.
  • Supervise assigned research personnel and provide direct input to leadership, in matters related to workload and individual staff performance.
  • Serve on various institutional committees such as Fiscal Review, Protocol Review Care, DSMB, and etc. to ensure that clinical research is in compliance with the various bodies.
  • Responsible for staff hiring, scheduling, performance evaluations, termination of staff, problem resolution and monitoring workload for quantity, quality and efficiency.
  • Coordinate content development, delivery of training. Includes revising course materials as necessary.
  • Periodically collaborate with Primary Investigators regarding protocol accrual to strategize regarding enhancement of accrual or facilitating closure.
  • Consult and collaborate with appropriate departments (i.e. UPMC Education Department, IRB) in order to provide training on departmental/company policies, procedures and best practices that support employee job function and career development.
  • Assist leadership and allied health professionals with creating strategic development plans for short and long term fund-raising initiatives and goals for the department.
  • Collaborate with the Director, nurse specialist and affiliated departments (i.e., UPMC Cancer Centers) to facilitate quality clinical research and quality gynecological cancer care across all systems throughout and affiliated with the UPMC network.
  • Ensure that the clinical trials and the conduct of clinical research complies with the Good Practice Guidelines, FDA, and other regulatory standards.
  • Communicate and negotiate with clinical trial sponsors, monitoring agencies, principal investigator, governmental agencies, staff, and the staff of the participating hospitals.
  • Develop procedures to address unique needs of projects and program implementation.
  • Work closely with sponsoring pharmaceutical companies to facilitate implementation of studies as well as to promote protocol compliance and efficient data collection.
  • Collaborate with ISD Computer Support Team to develop new databases needed in the department to meet research study needs.
  • Monitor the trials to make sure that a complete and accurate data set is obtained (i.e., target accrual goal).
  • Oversee the development and implementation of all materials needed to safely and effectively initiate clinical trials.
  • Collaborate with Primary Investigators to evaluate potential studies so that studies implemented and resources are allocated efficiently.

Qualifications

  • BSN or BS in related field, Master's preferred.  
  • Minimum of 3 to 5 years experience in clinical research.
  • Successful demonstration of the completion of the competencies required by the department/unit.
  • Supervisory skills necessary to plan organize and direct activities of assigned staff.
  • Must demonstrate expertise in human relations, ethical-decision making, problem and systems analysis, long and short-term strategic planning and proactive professional behavior.
  • Interpersonal and communication skills necessary to establish and maintain effective relationships with staff, investigators and Institutional Review Boards.
  • Thorough knowledge of clinical trail design and management, clinical monitoring, database management, FDA regulations and ICH Guidelines.
  • MS Office skills include PowerPoint, Excel and Word.

Licensure, Certifications, and Clearances:
  • Act 34 
UPMC is an Equal Opportunity Employer/Disability/Veteran

Salary Range: $24.08 to $41.23 / hour

Union Position: No

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