Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by Novella and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.
SENIOR CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
Collaborates with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC 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.
Assists in resolving any issues in order to ensure compliance with site file audits in conjunction with ISSC.
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 per the timelines defined in Novella SOPs by using approved Novella/sponsor templates 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.
May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
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.
Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
Assists with, and attends, Investigator Meetings for assigned studies.
Authorized to request site audits due to data integrity concerns.
Attends study-related, company, departmental, and external meetings, as required.
Ensures internal and study-related trainings are completed per Novella and/or study timelines; CTMS should be current at all times with the pertinent site updates/contacts.
Ensures all study deliverables are completed per Novella and study timelines
Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
Serves as mentor for junior CRAs and those new to the company and/or study.
Performs other duties, as requested.
BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is reqired; or equivalent combination of education, training and experience.
Computer literacy and knowledge of electronic data capture required.
Must possess excellent verbal and written communication, interpersonal, and organizational skills.
Requires and ability to work independently, prioritize, and work within a matrix team environment.
Prior Clinical Research Organization (CRO) experience preferred.
Prior project team leadership experience preferred.
Working knowledge of budget management preferred.
Must be able to travel domestically and internationally approximately 65%-85
EEO Minorities/Females/Protected Veterans/Disabled