For over 20 years, Meridian has partnered with pharmaceutical and biotechnology companies to research new drugs, medical devices, and diagnostics to help improve lives. The level of service, quality, and integrity we provide makes Meridian unique, but our reputation is great because of our people. Clinical research is tremendously challenging, yet it is incredibly rewarding. We value our employees for being all in, owning it, their teamwork, and sharing it. If you're searching for a career with purpose, integrity, and opportunity, then we want to hear from you!




The primary task of a site manager (SM) is to assist the Site Director (SD) in managing all aspects of the clinical research program of the site in addition to coordinating studies. The SM must be able to perform all tasks to execute, manage, and coordinate research protocols, recruit subjects, data collection and operations of several concurrent clinical research studies. The SM will assist in coordinating with the principal investigator(s) (PIs) and sub investigator(s) to integrate their research tasks with the clinical schedule. Working under the direction of the SD, develop and maintain effective leadership and working relationships with all site personnel in accordance with Meridian’s policies and procedures. Responsible for guiding site with effective leadership skills, professional demeanor, and positive approach. This role will also serve as the backup an secondary managerial role to the SD.



Responsibilities

Training and Lead

* Assist in defining and developing clinical research strategy and study protocols.
* Assist the SD in leading and executing clinical research studies and programs for the company.
* Distill research protocols into research plans with time lines and delegation of duties to appropriate research staff.
* Assist with all site staff development
* Assist in Conducting weekly site meetings to communicate information, provide continuing education, training and enhance teamwork.
* Manage and establish external clinical/contract research organization (CRO) and clinical study site relationships. Establish rapport and maintain contact and interact with monitors and sponsors to ensure customer satisfaction.
* Manage and establish rapport with various persons involved in the study, including but not limited to the patients, relatives/friends of the patients, doctors, pharmaceutical sponsors and all levels of the company.
* Act as liaison between site and other departments within company (budgets/contracts, finance, regulatory).
* Serve as an additional daily contact to PIs and Sub-Investigator(s).
* Assist with the development, implementation, and updating of SOPs to ensure consistent, safe, and efficient management of clinical trials and continuous improvements in the fiscal integrity of clinical research activities.
* Assist with the troubleshooting process to reach resolutions for any issues that arise during the course of a study.
* Maintain responsibility for the cost-effective requisition of needed equipment, supplies, and outsourced services with acceptable suppliers.
* Ensure site is maintained in an attractive, safe and efficient manner.
* Continually seek to improve site operations to enhance efficiencies to improve the overall profitability of the site.
Enrollment Accountability

* Assist in Providing leadership and manage the study recruitment to ensure enrollment goals are met or exceeded.
* Generate reports for supervisor on patient enrollment and tracking.
* Tabulate enrollment statistics and implement immediate actions to correct any inadequacies in reaching the site’s enrollment goals.
Feasibility Support

* Facilitate with the submission of feasibility questionnaires by providing prompt responses for necessary information regarding patient database and other study-related questions.
Quality Control

* Assist in Performing quality reviews to ensure the adequate execution of protocols and ensure adequate site staff training as needed. Ensure that training of investigators and staff are current for all research studies on an ongoing basis.
* Assist with the development and implementation of corrective and preventive actions to maintain a high-quality site.
* Maintain meticulous oversight of how the research plan is executed and the performance of each member of the team.
* Monitor and ensure site compliance with company policies and procedures, quality assurance guidelines and all federal, state, and local laws.
* Adhere to good clinical practice (GCP), International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), National Institutes of Health (NIH), Health Insurance Portability and Accountability Act (HIPAA), U.S. Food and Drug Administration (FDA) regulations and standard operating procedures (SOPs) and provides guidance to site staff on adequate compliance.
* Practical knowledge of document processes and reporting of serious adverse events (SAEs), 1572s, case review forms (CRFs), informed consent forms (ICFs), and other study related documentation to provide guidance to site staff as well as reviewing to ensure compliance.
* Maintain source documents and subject files in accordance with policies and procedures.
* Ensure accurate, confidential, and complete compilation of data.
* Assist in the maintaining of ongoing regulatory documents.
* Audit operations to ensure compliance with protocol and applicable regulations.
* Data analysis and reporting.
* Assistant in the Coordination of all aspects of the preparation for regulatory agency site visits, including paperwork required.
* Supervise the securing and shipping of clinical specimens as required by the protocol.
* Perform other duties not specifically listed in this job description as assigned by their immediate supervisor.





Requirements
* At least two years of experience in the medical field.
* Trained and experienced in clinical research.
* Familiar with the background of the study drug and requirements of the study.
* Have high ethical standards and professional honesty.
* Friendly and outgoing demeanor.
* Must demonstrate a passion for direct patient interaction.
* Demonstrate clinical competence, positive leadership and ability to work collaboratively with a multi-disciplinary team





Travel Requirements
* Occasional travel may be required in this position (less than 1 month per year)





Physical Requirements
* Prolonged periods of sitting at a desk and working on a computer.
* Must be able to lift 15 pounds at times.
* Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
* Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
* Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction, and having the ability to receive detailed information through oral communication, and making fine discriminations in sound.
* The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.





Meridian not only strives to move science forward and improve the lives of others, but we focus on improving the lives of our people by offering a competitive benefits package to all full-time employees. Meridian's benefits package includes eligibility for medical insurance, dental insurance, vision insurance, 401k with company match, seven paid holidays, paid time off, student loan reimbursement program, complimentary life insurance, disability insurance and so much more!


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