Sr. Clinical Research Associate

Company: InCarda Therapeutics
Location: Newark
Posted on: June 24, 2022

Job Description:

LOCAL CANDIDATES PREFERRED
Senior Clinical Research Associate (Sr CRA), independently or in consultation with the Clinical Trial Manager should be able to perform the following tasks: - - - - - - - -Demonstrate a solid understanding of therapeutic indications and the study protocol(s) assigned. - - - - - - - -Assist in project planning; timeline preparation, preparation and review of study plans, including the Clinical Monitoring Plan and review of eCRF guidelines/specifications. - - - - - - - - -Provide vendor management that may include EDC, IRT, Central Lab and specialty vendors. - - - - - - - -Develop clinical documents including ICFs, protocol support documents, Pharmacy Manuals, Lab Manuals, site support documents, and source documents. - - - - - - - -Select clinical Investigators appropriate to the therapeutic area and phase of the study. - - - - - - - - -Assess potential study sites to ensure the facility, staff and patient population are adequate for study conduct. - - - - - - - - -Facilitate budget planning and support site budget review, tracking and reconciling site related invoices of planned vs. actual spend. - - - - - - - -Independently manage study tracking, enrollment, site performance in collaboration with CTM - - - - - - - -Assess/review/ensure CRO monitoring quality, perform monitoring visits (PSV through closeout) as needed, review Monitoring Visit Reports (MVRs) and MVR metrics, attend SIVs and assist with site training, etc. - - - - - - - - -Review essential documents for IP release, provide label review, and preparation and coordination of IP supply - - - - - - - -Perform TMF reviews for assigned study(ies) and support Clinical Trial Assistant with the set up and management of the filing. - - - - - - - - -Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice by conducting site visits independently or in conjunction with the CRO. - - - - - - - - -Perform co-monitoring visits to evaluate CRO's CRAs, site performance and review source documents at the site to ensure compliance with the protocol. - - - - - - - - -Ensure the timely, accurate and complete collection and submission of study data. - - - - - - - - -Identify, address, and resolve issues and problems as they might occur. - - - - - - - - -Ensure collection of all data and remaining study supplies for return to the InCarda/CRO as appropriate. - - - - - - - - -Ensure that appropriate study documents are complete and properly filed. - - - - - - - - -Help prepare the site for possible inspections by Health Authorities. - - - - - - - - -Assist the InCarda/CRO in problem solving and provide consultation on monitoring and study related activities. - - - - - - - - -Demonstrate strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. - - - - - - - -Work independently in a fast-paced environment.This position may require up to 20% travel.Knowledge, Skill and Competency Requirements: - - - - - - - -Excellent oral and written communication skills, interpersonal relationship skills, negotiating skills, knowledge of scientific method, GCPs and regulations relating to clinical research. - - - - - - - - -Must have a working knowledge of computer technology and its application to the clinical environment. - - - - - - - - -Ability to develop tools and processes that increase measured efficiencies of the project. - - - - - - - - -Must be able to anticipate obstacles and proactively develop solutions to achieve project goals. - - - - - - - -Must have a general understanding of functional issues and routine project goals from an organizational perspective. - - - - - - - - -Ability to provide clear direction and guidance to others. - - - - - - - - -Demonstrated ability to lead by example and mentor others.

Keywords: InCarda Therapeutics, Newark , Sr. Clinical Research Associate, Healthcare , Newark, California