Clinical Research Site Manager/director
4 weeks ago
**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 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.
**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.
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