We are seeking a Site Manager to join our team in Mesa, AZ!
The Site Manager (SM) provides on-site, daily leadership with the execution and coordination of clinical research activities according to the organization's SOPs, ICH/GCP and FDA guidelines.
Utilizes universal precautions insures others are using universal precautions, obtains and maintains certification for the handling of potential infectious fluids and maintains safety for self, patient and others around them;
Work under direction of principal investigator. Must be a leader at the site and available to assist and guide staff in the activities of a research site. Responsible for guiding site through leadership skills and positive attitude;
Select, coach, counsel and develop all site staff to ensure they possess the necessary knowledge and skills to achieve operational and revenue objectives;
Develop and maintain effective leadership and working relationships with all site personnel in accordance with the Company's policies and procedures;
Conduct weekly site meetings to communicate information, provide continuing education, training and enhance teamwork;
Monitor and ensure site compliance with company policies and procedures, quality assurance guidelines and all federal, state and local laws;
Evaluate new operational methodologies that would increase efficiencies, provide competitive advantage and reduce costs;
Develop succession and training plans for all direct reports and assist or conduct annual performance appraisals;
Plan and organize the site to optimally meet the customer's needs. Analyzes collected data to identify patterns and trends for opportunities to improve client care/service performance;
Ensures 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;
Perform quality reviews to ensure the adequate execution of protocols and ensure adequate site staff training as needed;
Assist with the development and implementation of corrective and preventive actions to maintain a high quality site;
Provide 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 site's enrollment goals;
Direct and guide site staff on study specific tasks. Assist in training staff;
Becomes thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research studies at the site;
Adhere to GCP, ICH, NIH, HIPAA, FDA Regulations and SOPs and provides guidance to site staff on adequate compliance;
May assist in the maintaining ongoing regulatory documents;
Establish rapport with sponsor representatives and maintains frequent face-to-face, written and telephone contact 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;
Serve as Study Coordinator for a number of clinical trials as dictated by the site's needs;
Facilitate the completion and timely return of questionnaires to the Business Development department;
Perform basic lab procedures, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up, schedules patients, obtains informed consent, administers study medications;
Perform appropriate research protocol procedures which may include, but are not limited to: vital signs, pregnancy tests, blood collection and processing, ECGs, and alcohol breath tests and pain assessments;
Ensure study related reports and patient results are reviewed by an investigator in a timely manner and the investigator is providing adequate Principal Investigator oversight to ensure patient safety and compliance with the regulations;
BA/BS and a minimum of 2 years of experience as a Clinical Research Coordinator, or an equivalent combination of education and experience, is required.
Leadership experience is preferred.
An RN credential is a plus.
Certification as a Clinical Research Coordinator is preferred.
Exceptional organizational skills, attention to detail and follow through;
Strong proficiency in Microsoft Office programs (Outlook, Word) and Web applications;
Ability to type proficiently (35+ wpm);
Excellent verbal and written communication skills;
Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors and external customers;
Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads;
Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic;
Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other confidential information;
Must be a strong leader, set the example and willing to train others.
Synexus offers a comprehensive benefits package that includes medical, dental, and vision insurance offerings, life and disability insurance offerings, 401K, paid time off, and various other benefits and discount programs!
Synexus is an Affirmative Action and Equal Opportunity Employer.
Join Synexus as we expand and become an important part of a well-respected and growing company that believes the details of your career are every bit as critical as the work you do!
Synexus is the world's largest site network, with more than 195 sites and 1,500 employees globally. We provide customers with access to more than 100 million patients in key clinical development markets including Europe and the United States. Synexus is the leader in outsourced trial management services to the pharmaceutical, biotechnology and medical device industries. We have completed over 2,500 clinical trials in our 20+ years and operate from over 80 site network locations across the US!