Title: Site Manager (Manager of Clinical Operations/Clinical Research Manager)

Location: Pacific Research Network, San Diego

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off (PTO)
• Vision insurance
• Bonus opportunity

Job Description:

The Site Manager is a management position for Pacific Research Network (PRN), an Evolution Research Group portfolio company. The Site Manager is responsible for the daily administrative, recruiting, regulatory and financial business activities of the company.

Responsibilities:

• Coordinates 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.
• Works with new business development team in timely review and completion of new study feasibility queries.
• Works 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 to include monitoring and approval of accounts payable invoices and assist in tracking of accounts receivable.
• Coordinates 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.
• 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.
• Performs other duties as required.

Skills and Qualifications:

• Education and experience
  • B.A. or B.S. or equivalent professional level of experience.
  • 5 years of business operations experience in a medical office environment, clinical trial or research environment
  • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
  • Knowledgeable in medical terminology so as to communicate with physician offices, pharmacists and laboratory staff.
• Requirements
  • Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology
  • Bilingual skills in Spanish are required.
  • 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)

About us:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 22 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ 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.