CNS Clinical Research Site Director

Company
AES
Location
Atlanta, United States
Salary
Competitive
Posted
19 Jul 2019
Closes
01 Aug 2019
Ref
1synexus/TP/13884/2357
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Job Summary

Synexus is seeking a Site Director to join our CNS site in Atlanta, GA!

Role Responsibility

  • 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;
  • 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 study interest questionnaires to the Sponsor and/or Business Development department;
  • Maintain and obtain relationships with various vendors to assist in the conduct of research trials;
  • Understand all aspects of in-patient research and maintaining a good relationship with the contracting hospital. Ensure proper processes are in place and followed at the in-patient facility - from Award of a study to close out.
  • 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, alcohol breath tests, pain assessments, and other rating scales;
  • Ensure study related reports and patient results are reviewed by an investigator in a timely manner and the Principal Investigator is providing adequate oversight to ensure patient safety and compliance with the regulations;
  • Ensure timely completion of case report forms, ensuring accuracy of data and reporting of adverse events and deviations to IRB and 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, start-up activities, monitoring and close-out visits with Sponsor 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.


Ideal Candidate

  • Must have a minimum a BS/BA with 5 years of experience in Clinical Research, or an equivalent combination of education and experience, is required;
  • 1 year of leadership/management experience is required;
  • 1 year of psychiatric research or experience with the psychiatric population is required.
  • An RN credential is a plus. Certification as a Clinical Research Coordinator is preferred.
  • Exceptional organizational skills, attention to detail and follow through;
  • Expertise with GCP and FDA/ICH regulations; Must adhere strictly to protocol requirements and hold staff to same standards;
  • Prior CNS clinical and research experience providing care to people with varying degrees ofmentalillnesses;
  • Strong proficiency in Microsoft Office programs (Outlook, Word) andWeb 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 HIPAAguidelines, patient matters and other confidential information;
  • Must be a strong leader, set the example and willing to train others.


Package Description

We offer 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!

We are an Affirmative Action and Equal Opportunity Employer.

About Synexus

Accelerated Enrollment Solutions (AES) is a business unit of PPD that offers both sponsors and contract research organizations best-in-class site and enrollment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.

The array of AES services include strategic enrollment solutions that offer speed, certainty and commercial value to our clients. Acurian and Synexus have proven track records for enrolling patients and study conduct through proprietary, direct-to-patient recruitment methodologies and a global site network. When combined, these services provide a new standard of clinical trial productivity that delivers more patients from fewer sites in less time.