Clinical Research Associate Durata Therapeutics, Inc.
This role will be a key contributor to the company?s clinical development and primarily responsible for the hands-on management and monitoring of early and late stage clinical studies in infectious disease. This role will assist in the design, planning, implementation and monitoring of clinical studies and ensures studies are conducted, recorded and reported in accordance with the clinical protocol, standard operating procedures, ICH-GCP and other applicable regulatory requirements. Travel will vary upon level of experience, but must be willing to travel up 75%.
OVERSIGHT AND EXECUTION RESPONSIBILITIES:
The main responsibilities of the CRA role may include, but are not limited to, the following. Level of responsibility and independence will vary based on experience:
Collaborate with study management team to drive successful execution of global clinical studies in infectious disease.
Assist in protocol feasibility analysis, country assessment, site identification, and patient recruitment and planning.
Manage key study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, enrollment, data collection and close-out.
Establishes and maintains regular contact with investigators, vendors, and study sites to ensure ICH-GCP protocol compliance, and assessment of accrual rates.
Provide support to CRO and investigative sites to facilitate study conduct.
Train investigational site personnel to the clinical protocol and industry standards including ICH-GCP
Conduct monitoring visits at investigational sites, including site qualification, initiation, progress and close-out visits to ensure compliance with study protocols.
Work with site and study team to prevent, address, and resolve potential issues.
Prepare and submit monitoring visit reports in accordance with SOPs and procedural documents.
Communicate and document project specific information between trial sites and study management team and escalate issues in a timely manner to appropriate parties.;
Collaborate with Clinical Operations Team and CRO to collect data from study sites within established timelines.
Verify study data on source documentation and case report forms to ensure compliance with the study protocol. Identify and resolve data discrepancies.
Present and participate in investigator meetings and other study meetings as required.
Review adverse event reports and ensure the site is reporting events in a timely and appropriate manner.
Assist in the preparation of study documents including, but not limited to, clinical protocols and amendments, case report forms, informed consent forms, site training materials and clinical study reports.
Obtain, collate and file essential clinical documents in accordance with SOPs and procedural documents.
Act as a mentor to less senior CRAs to ensure proper training and development(dependent on level)
Participation in initiatives and/or other activities as directed.
To be considered for the Senior CRA level, must have at least 3-5 years of previous CRA experience (monitoring of investigational sites and managing, training and mentoring of other CRAs)
Must have an excellent understanding of applicable standards, regulations and ICH-GCP for clinical study conduct and a track record for ensuring quality data and superb site management.
Willingness to travel up to 75% of time; required to work from Branford, CT when not traveling.
Experience monitoring global clinical trials in infectious disease is a plus.
Must have a professional demeanor and appearance
Must have high degree of accuracy and attention to detail
Experience of coordinating people and time management
Demonstrated experience in computer skills including Microsoft Word, Excel, and basic templates
Makes independent choices and takes responsibility for own actions.
Excellent planning, organizing, interpersonal and leadership skills
Recognizes potential obstacles and works to resolve them within set timelines
Conscientious and precise in delivery of work even when under pressure
Collaborative and team oriented
Excellent oral and written communication skills
Exhibits a confident and influential approach
Understands customer needs
ABOUT DURATA THERAPEUTICS
Durata Therapeutics is an equal opportunity employer welcoming diversity in our workforce.
Durata Therapeutics, Inc. is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata is developing its advanced-stage lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections.
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