Director of Clinical Operations
2 weeks ago
Job Location
LOC022 RBA Richmond Behavioral Associates - Staten Island, NY
Director of Clinical Operations
Title: Director Clinical Operations
Location: Staten Island, NY
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 Director Clinical Operations is responsible for the management of analysis, design, development and implementation of diverse management-level monitoring and quality management, administrative, training, and information management tools and reports based on analysis, sound judgment and a high level of knowledge of specific study protocols. In executing these position responsibilities, the Director Clinical Operations is guided by Good Clinical Practices (GCP), International Committee on Harmonization (IHP) guidelines, and company standard operating procedures and policies.
Responsibilities:
Employee Management Responsibilities
- Serving as supervisor and mentor to all direct reports as detailed by the organizational chart.
- Performing and/or overseeing all HR responsibilities for reporting staff including but not limited to performance evaluations, corrective action plans, staff recognition, recruitment and onboarding of new employees, and management of staff schedules.
- Providing access and/or resources for all employees to complete the training needed to perform job responsibilities.
- Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
- Work with Site Director and Principal Investigator to assign primary clinical research coordinator.
- Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
- Oversees and is responsible for the conduct of all studies managed by direct reports.
- Develop a quality management plan for each protocol in conjunction with the Site Director and any applicable quality management team members.
- Assist with quality control measures and reviews.
- Work with the sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements.
- Work with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.
- Oversee the activities of direct reports as delegated.
- Attend the investigator meeting for each assigned protocol, as appropriate.
- In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.
- Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator
- Review and obtain informed consent from with potential study volunteers.
- Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.
- Maintain organized, accurate and complete study records.
- Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
- Enter data as appropriate for protocol (paper-electronic data capture)
- In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.
- Perform study close-out procedures.
- Store study records appropriately
- 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.
- Education and experience
- College degree preferred.
- Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
- Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
- Knowledgeable in medical terminology to communicate with physician office and laboratory staff.
- Demonstrate the initiative to act independently, initiate activity as required and make appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
- Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change.
- Requirements
- Excellent communication skills (interpersonal, written, verbal)
- Ability to perform overnight business travel.
- Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
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