Clinical Research Associate (Contract - West Coast) - NCR
Novella Clinical Resourcing is currently seeking an experienced Oncology CRA for a long-term, part-time contract need. Ideal candidate would be located along the West Coast, preferably Northern West Coast.
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. This position may also serve as Lead 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.
- Perform SAE review and reconciliation
- May review protocols, eCRFs, study manuals and other related documents, as requested by 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.
- May assist with, and attend, Investigator Meetings for assigned studies.
- Attends study-related, company, departmental, and external meetings, as required.
- May serve as mentor for new clinical study monitors.
- Authorized to request site audits due to data integrity concerns.
- Ensure 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.
- Ensure all study deliverables are completed per Novella and study timelines.
KNOWLEDGE, SKILLS AND ABILITIES:
- Working knowledge of all functional areas of clinical trials and medical terminology.
- Must possess 2 years of oncology and/or medical device experience.
- Experience in monitoring and/or coordinating clinical trials required.
- Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
- Demonstrated ability to form strong functional relationships
- Strong organizational and interpersonal skills.
- Ability to reason independently and recommend specific solutions in clinical settings.
- 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.
MINIMUM RECRUITMENT STANDARDS:
- BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) or equivalent amount of education.
- A minimum of two (2) years of monitoring/site management experience is required.
- 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 65%-85%.
EEO Minorities/Females/Protected Veterans/Disabled
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