The Lead Clinical Research Associate may perform any of the following tasks :
Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators.
Evaluates the capability of the site to successfully manage and conduct the clinical study.
Collaborate 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
Perform 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.
Assists with, and attends, Investigator Meetings for assigned studies.
Train site staff on the EDC system and verify site computer system.
Assist in resolving any issues in order to ensure compliance with site file audits in conjunction with ISSC.
Assure 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.
Document 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.
Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification.
Work with sites to resolve data queries.
May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and / or PM.
May serve 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.
Assist CTM and / or PM in review of project budgets, monitoring costs, potential overruns and propose / implement cost effective solutions.
Assist the study management in identifying and generating changes in scope
Perform 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.
Authorised to request site audits due to data integrity concerns.
Attend study-related, company, departmental, and external meetings, as required.
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
Conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.
Serve as mentor for junior CRAs and those new to the company and / or study.
Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.
Review and approve CRA travel expenses and time sheets.
Perform other duties, as requested.
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.
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 / BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of two (2) years of monitoring / site management experience is required;
or an equivalent combination of education, training and experience.
Computer literacy and knowledge of electronic data capture preferred.
Must possess strong verbal and written communication, interpersonal, and organisational skills.
Must be able to travel domestically and internationally approximately 65%-85%.