Clinical Research Site Manager/director - Bellaire, United States - Evolution Research Group

Evolution Research Group
Evolution Research Group
Verified Company
Bellaire, United States

1 month ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Title:
Site Manager

Location:
Bellaire, TX

About us:

The Site Manager is responsible for the daily administrative, recruiting, regulatory and financial business activities of the company.


Responsibilities:


  • Coordinate the review of all new clinical research protocols as they relate to the clinical and business feasibility aspects of conducting the study.
  • Represent the company to pharmaceutical companies and physicians in a professional business manner.
  • Work with new business development team in timely review and completion of new study feasibility queries.
  • Work with budgets and contracts team in development of new studies, approving final budgets.
  • Develop and maintain relationships with affiliate physicians, coordinating activities to ensure affiliate sites are functional, efficient, and cost effective.
  • Responsible for daytoday financial activities including monitoring and approval of accounts payable invoices and assist in tracking of accounts receivable.
  • Coordinate end of month accounting activities with finance team.
  • Completion and submission of weekly Operational Reports.
  • Provide support and supervision of the patient recruitment department, coordinating the design and implementation of patient recruitment programs.
  • Provide support and supervision for the regulatory affairs department ensuring 100 percent compliance with all federal regulations, sponsor protocols, and internal/external standard operating procedures.
  • Provide support and supervision for the computer systems/database management department.
  • Work with Clinical Research Coordinators and other site staff to ensure efficient operations through a proactive teamwork environment.
  • Schedule employees to ensure company business activities are conducted to meet customer expectations and satisfaction.
  • Ensure fair, equitable and consistent administration of all corporate and company policies.
  • Coordinate personnel and payroll activities with Human Resources as required in a timely and efficient manner.
  • Work with Clinical Research Coordinators to assess clinical and administrative staffing needs, including cost benefit analysis.
  • Facilitate communication between administrative, patient recruitment and clinical staff to ensure study development, site initiation, patient enrollment and study documents are completed to meet sponsor/contract obligations.
  • Provide administrative support to Clinical Staff as needed.

Skills and Qualifications:

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Education and experience

  • Bachelor's degree in business/marketing or related field or equivalent professional level of experience

:


  • 5 years of business operations or in a business, medical office environment, clinical trial, or research environment, working with children.
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Requirements

  • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology
  • Selfdirected with the ability to respond to problems with professionalism and flexibility. Progressive management style with established supervisory abilities. Experience in computerized bookkeeping systems.
  • Knowledge of GCPs, FDA regulations, quality assurance and pharmaceutical industry desirable.
  • Excellent interpersonal skills, written and oral communication skills.
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