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Clinical Research Site Manager/Director

4 months ago

Bellaire, United States EVOLUTION RESEARCH GROUP Full time
Job Details

Job Location
LOC009 HDR First Surgical Hospital - Bellaire, TX

Site Manager/Director

Title: Site Manager

Location: Bellaire, TX

About us:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes, and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

Job Description:

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 day-to-day 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.
  • Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives.

Skills and Qualifications:
  • 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.
  • Requirements
    • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
    • Knowledgeable in medical terminology
    • Self-directed 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.
    • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)