Title: Clinical Research Site Manager/Director

Location: RBA-Staten Island, NY

Job Description:

The Site Manager is responsible for the daily administrative, recruiting, regulatory and financial business activities of the company. The Site Manager will work closely with the Chief Medical Officer, Principal Investigators, Recruitment Team and Clinical Research Coordinators to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective.

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.
• 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.
• 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.

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
  • Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology
  • 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 21 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.