CRA II (439155)
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POST DATE 9/12/2016
END DATE 10/9/2016
JOB DESCRIPTIONJob Description:
OVERVIEW:Responsible for implementing and monitoring clinical trials and expands experience in clinical trial and vendor management procedures. Works closely with Investigators, Site Personnel and Vendors to ensure compliance with protocol and overall clinical objectives. Develops independence in performing routine work and develops leadership skills. Identifies projects/tasks and works with Clinical Trial Manager to complete. Develops ability to organize, manage and set priorities for multiple tasks. Demonstrates ability to carry out all CRA II functions with minimal supervision. In collaboration with manager and/or Lead CRA, maintains consistent CRF data quality and discrepancy interpretation across sites. Uses an established understanding of the disease, molecule and indication. Maintains high level of professionalism within Client and at the study sites. Key Accountabilities/Core Job Responsibilities: Conducts site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct Co-monitors with more junior CRAs to assist manager/Lead CRA with on-site monitoring and study visit training, as needed Assists in CRF design and CRF guidelines Develops study tools and guidelines to be utilized by study sites Assists in the process used to evaluate and select potential investigators and sites Prepares monitoring reports per SOPs Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues and assigned sites Participate in Vendor selection and Vendor management activities. Participate in Quality Oversight visits for other CRAs and CRO CRAs. Presents at Investigator/Study Coordinator meetings and represents Client in the technology booth at scientific meetings, as necessary Understands study timelines and manages sites to meet timelines Collaborates with team to maintain consistent CRF data quality and discrepancy resolution across sites Proactively identifies and works to resolve enrollment and data completion issues Performs manual, in-house review of CRF data in clinical database for completeness and accuracy Reviews site s informed consents against the consent template for presence of all GCP requirements and protocol specific information. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand Develops basic skills in writing informed consent templates, protocol and other documents. Applies knowledge of regulatory requirements/SOPs to documents Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy Ensures study records are auditable both at investigational sites and in-house Responsible for tracking IND Safety Reports for assigned sites Initiates drug/device shipments and ensures that drug supplies are adequate for assigned studies Assists manager/Lead CRA with the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies Responsible for initiating and tracking quarterly site payments Communicates status of trial to manager and team Responsible for coordinating and leading various functional area projects and tasks Develops basic skills in functional area team leadership Partners with team members and other functional areas within Client such as Regulatory, QA, Legal, BiometricsQualifications: Good verbal and written communication skills are required. Attention to detail and organizational skills Working knowledge of GCP and FDA regulations Proficiency in MS Word, Excel and Powerpoint Experience: 2+ years of CRA experience in an industry setting, or four years of pharmaceutical/health care field experience including 1 year previous experience as a CRA. Experience in clinical research at either a hospital or pharmaceutical/biotech company or a CRO.Education Requirements:(degree, certifications, etc.): Include must have and preferred BS/BA degree in a life science, RN, or related fieldPreferred Skills/Abilities:On a continuous basis, sit at desk for prolonged period of time at company facility to intermittently answer telephone, file/fax/or copy documents, and write or use a keyboard to communicate through written means. Walking and lifting up to 20 pounds may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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