Radiant Research / Synexus is comprised of over 80 clinical research locations nationwide. Our clinical research centers provides a critical service to biopharmaceutical companies by recruiting study participants into clinical research, conducting the clinical research protocol and collecting the data necessary to support the safety and efficacy of the drug company's product to the FDA. Our client list includes every major pharmaceutical company and contract research organization and many biotechnology and medical device companies.
We are seeking a full time CNS Site Director in Atlanta, GA!
In this role you will provides on-site, daily leadership with the execution and coordination of clinical research activities according to the organization’s and FDA guidelines. The CNS Site Director (SD) provides leadership and oversight of all daily clinical research activities according to the organizations SOPs, GCP and FDA/ICH guidelines and is responsible for the growth and development of Psychiatry and Central Nervous System (CNS) and general medicine research.
The SD proactively participates in the quality reviews and works with the Region Director, Director of Clinical Operations and/or the VP of Operations to implement the appropriate corrective actions. The SD provides the site staff with expertise and guidance on recruitment and enrollment of the clinical trials to ensure site(s) profitability. The SD functions as the organization’s liaison to the physician and physician practice to ensure the appropriate Investigator oversight is maintained at all sites she/he is responsible for. The SD takes accountability for the site’s financial performance and continually seeks out improvements to enhance the overall business. The SD may maintain a study load to support revenues and decrease operational costs. The SD provides training and mentoring to site staff and the Investigator, and serves as the onsite leader and exemplifies the core values of the organization. The Site Director must also be able to perform clinical tasks (i.e. phlebotomy, EKGs, vital signs, etc.) and fully function as a clinical research coordinator.
Specific job responsibilities will include:
Utilize 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;
Working under the direction of principal investigator, develop and maintain effective leadership and working relationships with all site personnel in accordance with the Company's policies and procedures; Must be a leader at the site and available to assist and guide staff in the activities of a CNS research site. Responsible for guiding site with effective leadership skills, professional demeanor and positive approach;
Responsible for the cost effective requisition of needed equipment, supplies, and outsourced services with acceptable suppliers;
Assume full site P&L responsibility. Assists senior management in the development and preparation of the site's annual budget, and is responsible for the execution of that budget. Analyze and evaluate the activities, costs, operations, budgets and forecast data to determine site progress towards stated goals and objectives;
Ensures site is maintained in an attractive, safe and efficient manner;
Select, coach, counsel and develop all site staff to ensure they possess the necessary knowledge and skills to achieve quality 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;
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;
Responsible for completion of case report forms, ensuring accuracy of data and reporting of adverse events to sponsor;
Practical knowledge of document processes and reporting of SAEs, 1572s, CRFs, ICFs, and other study related documentation to provide guidance to site staff as well as reviewing to ensure compliance;
Ensure that training of investigators and staff are current for all research studies on an ongoing basis;
Provide patient education regarding disease process and involves patient and family in decision-making processes;
Maintain accountability of own ongoing professional growth and development;
Perform necessary functions as approved by the corporate office, for the conduct of clinical research and escalates appropriately;
Maintain strict confidentiality of patients, employees and company information at all times and adheres to HIPAA Guidelines;
Coordinate and conduct pre-study, initiation, monitoring and close-out visits with the pharmaceutical representative, including completion of minutes and follow-up reports;
Maintain contact and interact with monitors and sponsors to ensure customer satisfaction;
Acts as Liaison between site and other departments within company (budgets/contracts, finance, regulatory)Serve as main daily contact to principal investigator;
Attend investigator meetings as required;
Ensure growth and advancement of CNS research at the site and within the region;
May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.
A Bachelor’s degree (BS/BA) AND a minimum of 3 years of experience as a Clinical Research Coordinator AND a minimum of 2 years of leadership/management experience, or an equivalent combination of education and experience, is required. A Master’s degree is highly preferred.
Prior CNS clinical and research experience providing care to people with varying degrees of mental illnesses is highly preferred.
An RN credential AND/OR certification as a Clinical Research Coordinator is preferred.
Must have expertise with GCP and FDA/ICH regulations; must adhere strictly to protocol requirements and hold staff to same standards;
Strong proficiency in Microsoft Office programs (Outlook, Word) and Web applications;
Ability to type proficiently (35+ wpm);
Exceptional organizational skills, attention to detail and demonstrated human relations and effective communication skills required;
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 sensitive information.
Radiant Research / 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! Join us as we grow! Visit us at www.radiantresearch.com to learn more about us!
We are an Affirmative Action and Equal Opportunity Employer!
Additional Salary Information: Competitive salary dependent on qualifications
Clinical Research Advantage is a leader in outsourced trial management services to the pharmaceutical, biotechnology and medical device industries. CRA has completed over 1,800 clinical trials in its 20 years. CRA is comprised of community based Investigators plus an experienced staff of Clinical Research Coordinators. CRA currently operates from its 33 site network across seven states. The key... to our success has been the development of research departments within established medical practices. Our research staff is positioned in the clinic, which affords CRA rapid recruitment of reliable, qualified subjects into clinical trials. Our expertise continues throughout the trial, providing full execution of the protocol with complete and accurate data. CRA enjoys a strong reputation for quality and is focused on patient care.
In 2011 CRA was voted one of the 25 Top Workplaces for Women by AZ Magazine and in 2012 CRA was named "Best Clinical Site Network" by the ViE Awards!