Freshers Clinical Research Associate Jobs For Life Sciences at CLINICA Research, Apply on Biotecnika
Job Description – Clinical Research Associate (CRA)
Company: CLINICA Research
Location: Navi Mumbai
Qualification: Bachelor’s degree in life sciences or related field; or equivalent combination of education, training, and experience
Experience: 0–1 year
Salary: ₹20,000 per month
Essential 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.
• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; interim/Periodic 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.
• 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 CLINICA SOPs by using approved CLINICA/sponsor templates and reports.
• Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product
• 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 Project Manager and/or Lead/Sr. CRA.
• Serves as primary contact between CLINICA 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 CLINICA and/or study timelines; Study tracking tools should always be current with the pertinent site updates/contacts.
• Ensures all study deliverables are completed per CLINICA and Project timelines.
• Conducts Field Evaluation Visits and field training of CRA Is, Jr. CRAs and other CRA -Trainees.
• Serves as mentor for junior CRAs and those new to the company and/or study.
• Archival of study documentation. Participation in other department initiatives/activities.
• Negotiation & obtaining Investigator agreement on site budget, payment to the sites.
• Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.
• Interacting with MW for CSR appendices.
• Performs other duties, as requested.
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