JOB LISTINGS

Research Project Coordinator

Employment: Research Project Coordinator

Type: Full Time

Location: Houston, TX

"You can make a difference in the life of an oncology patient and find your career satisfaction by joining our team of healthcare professionals today."

About the Position

The Research Project Coordinator functions as an integral part of the Research Team and provides direct support to the practice’s clinical research program, it’s clinical trial pipeline development and implementation of projects for the Research Department.

 

SCOPE:

The principal role of the Research Project Coordinator is to coordinate and support the Research Department Administrator in the daily activities related to new research opportunities presented to the Research Department, during the pre-study selection process, study start-up process and study site initiation as well as the regulatory aspects during the process. The Research Project Coordinator functions under direct supervision of the Research Department Administrator.  This role will also support Regulatory and Project Management as well as additional duties and other special interest projects as assigned.  This position will require the ability to communicate effectively with the physicians, coworkers, research sponsors, pharma clients, and collaborators. 

The assigned functions include duties within the following three areas:  Business Development, Regulatory and Project Management.

Shift Schedule:

• Mon - Fri: 8am - 5pm

Benefits:

• Insurances: Life, medical, dental, short term and long term disability
• 401K
• Free parking
• PTO
• Holidays 
• Competitive salary

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

• Support the Research Department Director and Research Department Administrator to bring the appropriate clinical trial pipeline to the practice. 
• Support the clinical trial start-up process and work closely with the Research Department Administrator to complete the start-up tasks as well as work closely with sponsor study teams to ensure new trial implementation needs are met.
• Develop relationships with pharma sponsor and their Medical Science Liaisons who bring visibility to their company’s pipeline of investigational products to the practice.
• Provide direct support to clinical and operational study opportunities, projects, or initiatives to the leadership involved in clinical research.
• Work closely with the Research Department Director and Research Department Administrator in the implementation of operational infrastructure of systems, processes, and personnel designed to accommodate the rapid growth objectives of the practice.
• Assist the Research Department Administrator with business development activities to effectively grow the organization and contribute to financial objectives.

Regulatory

 

Responsible to support the overall planning and direction of clinical regulatory activities that lead to timely regulatory submission.  To support this objective will require:

• • Review invited protocols and manage the adequate maintenance of submission files.
  • Provide support in the submission process of: 1) confidentiality agreements, 2) feasibility questionnaires, 3) contracts, and 4) Institutional Review Boards 5) Other, based on the characteristics of the study and its collaborations.
  • Manage submissions related to supplements and amendments to update registered product information.
  • Coordinate, plan and execute site initiation visits.
  • Negotiate with outside agencies as needed to resolve key regulatory issues.
  • Expedite approvals of the clinical trials and services.
  • Communicate regulatory changes and updates to staff and management.
  • Monitor and update national and international registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel.

Project Management

Responsible for overall organization and administrative project management of clinical research initiatives for the clinical research team.  To support this object will require:

• Assist in the planning, efficient implementation and activation of research projects on behalf of the practice such as the CTMS.
• Promote active and courteous communication and interactions with research sponsors and trial collaborators.
• Support effective outreach and patient recruitment endeavors required by each clinical trial.
• Facilitate study tools to nurses, pharmacists, Clinical Research Coordinators and data team.
• Attend practice management meetings that involve the Department of Research as well as represent Research on an as needed basis. 
• Create and maintain clinical research databases to capture outpatient and inpatient research activity.  Data should include information related to monthly patient accrual by physician, office, protocol, protocol waiting list, performance of clinical trials etc.
• Clearly and effectively communicate projects, rationale and developmental stages with other members inside and outside the Research Department.
• Assignment to clinical trial oversight will be done on an as needed basis, with close oversight of assignments from the research manager and the department director.
• Demonstrate basic knowledge of all active projects and assist in the creation and maintenance of a protocol synopsis for individual viewing and group presentations.
• Support expectations of the clinical studies as well as help to implement proper research procedures that effectively support trial protocols, drug dosing, administering, injections, drug storage, reimbursement, invoicing, data management, regulatory, etc.

 ADDITIONAL DUTIES AND RESPONSIBILITIES:

• • Attend local, regional, national or international research/scientific meetings as required.
  • Provide coverage for research manager on an as needed basis. 
  • Other duties as assigned.

EDUCATION and/or EXPERIENCE:

• Degree in the life or health sciences or business
• Minimum of two years of experience in clinical research projects.
• Proficiency with computer systems and Microsoft Office (Outlook, Word, Power Point and Excel) required.

LANGUAGE SKILLS:

English

WORK 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 essential functions.  Work is performed in an office environment and requires frequent interaction with the research and non-research staff, physicians, study sponsors and regulatory agencies.  Work will require limited travel by air or automobile approximately 15% of time such as to other locations within the practice or investigators meetings.

COMMENTS:

This description is intended to describe the essential job functions, the general supplemental functions and the essential requirements for the performance of this job. It is not an exhaustive list of all duties, responsibilities and requirements of a person so classified. Other functions may be assigned and management retains the right to add or change the duties at any time.

About Oncology Consultants

Oncology Consultants has been a premier adult medical oncology & hematology practice in Houston, TX for over 35 years. Our healthcare team is committed to provide state of the art cancer treatment in a caring environment as we continue to expand our oncology services in the metropolitan region.

Oncology Consultants is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.

Medical Center | Memorial City | Sugar Land | Katy | Willowbrook | Southwest Northwest | West Houston

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