Sr CRA (United States) - CNS
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Do you want to be a part of a global top 10 CRO* INC Research is a full-service contract research organization, providing the full range of Phase I to IV clinical development services for the world s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we ve continued to improve what we do.
Our CNS therapeutic team is composed of more than a dozen highly accomplished CNS drug developers from pharma, CRO, academic, and neuroscience backgrounds. Our therapeutic leaders take on major programs and individual studies according to their indication expertise. They take accountability for the advice they give, and personally manage their global project teams accordingly. They assess the development plans, resourcing needs, and culture of the sponsor and translate that understanding to the project teams that they lead. Through meaningful and accountable leadership, project teams practice the art of CNS trial implementation while using our disciplined operational framework, the Trusted Process , to guide reliable operations.
CNS research is inherently susceptible to noise, placebo effects, and statistical power degradation. We ve developed a number of teams and procedures to overcome these challenges, improving site selection, recruitment, and ultimately data quality. These innovations are unique to INC Research and operate to increase the efficiency and effectiveness of project teams. Many of our sponsors credit these innovations with providing them actionable and positive pivotal trials in difficult areas.
We are currently looking to strengthen our Central Nervous System Clinical Monitoring team in North America and are seeking a Senior Clinical Research Associate to be a home-based employee.
A BRIEF SUMMARY OF DUTIES YOU WILL BE INVOLVED IN:
* MONITORING - Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits superior time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits.
* DATA HANDLING - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Highly proficient with multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed.
* REPORTING AND TRACKING - Completes and submits reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
May assume role as Lead CRA and/or assist with LCRA activities, e.g. tool development, study plans, and team training. Performs other work-related duties as assigned. Extensive travel may be required (more than 50%).
WHY CHOOSE INC RESEARCH:
It takes skill and passion to develop medicines the way we do. Don t worry if you ve got the passion part, we ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry. We ve got an attitude at INC: Can do, I own it. Absolutely everyone has ownership of what they do here; and because we re given the freedom and responsibility to really own our projects, we can take them to new levels. This means we can take our careers wherever we want them, too.
We were ranked Top CRO to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
INC Research is a company headquartered in the United States and that the personal information collected on its websites may be sent to, stored or processed in the United States or to any other country in which INC Research or its affiliates, subsidiaries or agents maintain facilities. While INC Research is committed to providing your voluntarily disclosed employment application information with a reasonable level of privacy protection, you should know that the general level of protection for personal information in the United States may not be the same as that provided in other countries. By using the INC Research website and/or providing INC Research with personal identifiable information, you fully understand and unambiguously consent to the transfer and the collection and processing of such information in the United States.
To succeed in this role you will need the following skills/experience:
* Education - BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience
* Previous practical experience in conducting clinical pharmaceutical research studies as a Clinical Research Associate or Site Monitor, with a pharmaceutical company or CRO, including independently performing Pre-Study, Site Initiation, Interim Monitoring and Close-out Visits
* Previous CNS experience (encompassing Neurology, Psychiatry, and/or Pain) in clinical trials.
* Strong understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines
* Excellent command of written and spoken English language
* Ability and willingness to travel 75% of the time, primarily via plane, on a regular basis
Must have valid, current driver's license and ability to secure corporate credit card.
ACRP CCRA or equivalent certification/credentials strongly preferred.