POSITION TITLE: Clinical Research Associate II
REPORTS TO: CRA Manager
Responsible for monitoring Novella clinical trials to ensure that investigators are conducting the research within requirements of the clinical protocol, that research is conducted in accordance with applicable federal regulations and guidelines, that data quality on initial review meets acceptable clinical standards, and the rights and safety of human subjects involved in a clinical study are protected.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
· Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.
· Works with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.
· Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
· Trains site staff on the EDC system and verifies site computer system.
· Conducts periodic site file audits to ensure compliance with GCPs and Novella standard operating procedures.
· Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters in a timely manner using approved Novella/sponsor forms and reports.
· Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
· Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
· Reviews protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager.
· Serves as primary contact between Novella and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
· Assists with final date review and query resolution through database lock.
· Performs study close-out visits.
· Assists with, and attends, Investigator Meetings for assigned studies.
· May serve as mentor for new clinical study monitors.
· Authorised to request site audits for reasons of validity.
KNOWLEDGE, SKILLS AND ABILITIES:
· Knowledge of clinical research process and medical terminology.
· Twenty-four months experience in monitoring and/or coordinating clinical trials preferred; experience in a clinical setting a plus.
· Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
· Strong organizational and interpersonal skills.
· Ability to reason independently and recommend specific solutions in clinical settings.
· Able to mentor entry level CRAs.
· Understand electronic data capture including basic data processing functions.
· Understand current GCP/ICH guidelines applicable to the conduct of clinical research
· Able to qualify for a major credit card.
· Valid driver’s license; ability to rent automobile.
· Willingness and ability to travel domestically and internationally, as required.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
· Ability to travel domestically and internationally
· Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
· BS/BA (or equivalent) in one of the life sciences with a minimum of two years of field monitoring experience or equivalent amount of education/experience.
· Computer literacy and knowledge of electronic data capture preferred.
· Must possess strong verbal and written communication, interpersonal, and organizational skills.
· Must be able to travel domestically and internationally approximately 50%-75%.
This position is exempt from the Fair Labor Standards Act; employees are not eligible for overtime compensation.
Novella Clinical - 22 months ago
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