JOB TITLE & CODE:

Research Project Coordinator

DEPARTMENT:

WVU Medicine Heart and Vascular Institute

REPORTS TO:

Director, Research & Quality

FLSA STATUS:

Exempt

 

 

 

 

 

 

 

 

 

 

POSITION SUMMARY:
This position will oversee the coordination and management of research projects from start up through completion within the Heart & Vascular Institute. Accountable for implementing objectives and goals for each project and working directly with staff to assure the timelines are met. The role will coordinate/manage, analyze, and provide accurate and relevant data for administrators to track and make informed decisions for the conduction of  projects. Supports the research team in coordinating/managing start-up activities, facilitating progress across team members throughout the study, and providing tools, metrics, and analytics that foster all research activities.
Works directly with Administrators, clinical trial sponsors, physicians, clinical research specialists, research regulatory and business, and other staff across all departments. Responsible for maintaining the Clinical Trial Management software system.

MINIMUM QUALIFICATIONS

EDUCATION, CERTIFICATION, AND/OR LICENSURE:

1.

Bachelorís degree.

2.

Valid Driverís License

EXPERIENCE:

1.

One year of experience in research, management, administrative, or related experience.

3.

Six months of experience in IT related projects and/or responsibilities.

 

PREFERRED QUALIFICATIONS:

EDUCATION, CERTIFICATION, AND/OR LICENSURE:

1.

Masterís Degree or related experience equivalent.

EXPERIENCE:

1.

Four years of experience in research, management, administrative, or related experience.

2.

One year of experience with a research database or Clinical Trial Management Software System.

3.

Six months experience using and/or managing a research database.

4.

Two years of experience in IT related projects and/or responsibilities.

 

CORE DUTIES AND RESPONSIBILITIES: The statements described here are intended to describe the general nature of work being performed by people assigned to this position. They are not intended to be constructed as an exhaustive list of all responsibilities and duties. Other duties may be assigned.

1.

Provide a lead role in managing, executing and monitoring multiple research projects through all phases of the study life cycle.

2.

Responsible for creation and management of research projects including clinical research trials within approved datasets.

3.

Ensure Director has timely and accurate data on areas including schedules, timelines, progress, and challenges across all research studies.

4.

Prepares study reports utilizing a variety of computer software packages including Clinical Trial Management System and MS Office Suite: Word, Excel, PowerPoint, Access and Visio. Proficient utilization of EMR - Epic, Centricity and CCI.

5.

Maintains timely, study-specific documentation that reflects an accurate, complete, and legible record of study activities.

6.

Develop agendas and lead the internal project meetings including Kick-off meetings, Study Qualification Visits, Study Initiation Visits, Monitoring Visits, etc. with sponsors and internal teams.

7.

Coordinates a variety of complex activities involved in the start-up and execution of research studies.

8.

Establish and manage performance dashboards, analyze event triggers and alerts and determine appropriate follow-up for study coordinators or others to act upon.

9.

Interacts with internal contacts such as research staff; principal investigators; clinical staff; administrators; various departments; and Directors to discuss and collaborate on research issues; and to design, develop, and coordinate research plans and techniques for research trials.

10.

Act as main line of communication between study site personnel and the sponsor. 

11.

Responsible for site feasibility questionnaires, including working with various departments including Quality and Biostatistics to gather the correct data.

12.

Respond to study related questions from sites, vendors and sponsors in a timely fashion.

13.

Provides Research Business Coordinator with ongoing data regarding staff output on study activities.

14.

Point person for IT related activities such as image upload requirements for studies and ensuring appropriate access to internal and external software systems for all studies and roles.

15.

Manages payroll for Research Department staff.

16.

Leads, coordinates, and has direct responsibility for a wide variety of special projects on behalf of the Directors or Administrators.

17.

Ensure compliance with study tools, training materials and standard processes, policies and procedures through ongoing auditing activities.

18.

Familiarize and become highly knowledgeable with all study/clinical trials protocols currently assigned to the department.

19.

Independently participates in activities to increase knowledge base and performance.

20.

Assists in ensuring compliance with WVU Institutional Review Board, Good Clinical Practice guidelines and federal regulations related to clinical research.

 

 

 

PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1.      

Stand and walk for extended periods of time.

2.      

Lift, push, pull, carry items up to 50 pounds in weight.

3.      

Ability to travel.

 

 

 

WORKING ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1.

Occasional interaction with research study subjects on nursing floors.

2.

Normal working office environment.

3.

Ability to travel and to stay off site overnight while conducting research activities.

 

 

SKILLS AND ABILITIES:

1.

Knowledge and experience in Microsoft Office Suite (excel, PowerPoint) and other relevant software Understanding /experience using Clinical Trial Management Systems (CTMS); OnCore Enterprise Research Management System preferred.

2

Excellent written, oral, and interpersonal communication skills.

3.

Prior clinical research and trial experience.

4.

Complex problem solving skills, teamwork skills, and critical thinking skills desired.

5.

Results-oriented approach to work delivery and output.

6.

Ability to influence without authority.

7.

Ability to handle conflicting priorities.

8.

Ability to work independently.

9.

Excellent organization skills and ability to prioritize a variety of tasks.

10.

Exceptional emotional intelligence and critical thinking skills necessary to evaluate and respond to team progress and related group dynamics.

11.

Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.

12.

Demonstrates the ability to raise questions and seek additional information as necessary to complete job responsibilities.

13.

Experience developing relationships with physicians and staff.

14.

Planning, time management and prioritization skills.

15.

Analytical skills include the technical aspects of gathering data for purposes of study-related activities.

 

16.

Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Updated: December 3, 2021