• Sr CRA Jobs in Colombia

  • Iqvia
  • Colombia
  • Save Job
  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

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 ISS 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 ISS 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 to ensure compliance with site file audits in conjunction with ISS
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 IQVIA
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 IQVIA 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 IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts
Ensures all study deliverables are completed per IQVIA 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

LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES

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 studyCollaborate with the ISS 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 ISS 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 to ensure compliance with site file audits in conjunction with ISS
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 IQVIA
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 IQVIA 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
Authorized to request site audits due to data integrity concerns
Attends study-related, company, departmental, and external meetings, as required
Ensure internal and study-related trainings are completed per IQVIA and/or study timelines; CTMS should always be current with the pertinent site updates/contacts
Ensure all study deliverables are completed per IQVIA and study timelines
May 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

TECHNICAL CTM ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES

The Technical CTM may perform any of the following tasks for oncology studies

Create master tracker(s) to house information generated from various reports such as
and CM_Data_Cleaning_Report_By_Subject both Business Objects reports
Reconcile patients that have come off treatment and off study
Generate and review various IL2 reports
Works closely with CDRC to ensure data is further reviewed and discrepancies documented
The Technical CTM may participate in CDRC review and aid in Patient Profile review, as necessary
There may be additional tracking required as a result of CDRCs review

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 18th Mar 2020

Key Skills:

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