Hiring Clinical Research Associate for a Medical

16 hours ago

Thane, India T A Solution Full time

Hiring Clinical Research Associate for a medical research organization in Thane, Mumbai location
Posted on -December 4, 2021

CRA (Clinical Research Associate)

**1. Education**: M Pharm (Pharmacology) /M.SC/ B Pharm

**2. Salary**: 20-30K

**3. Experience**: Fresh / 1-2 Years (Site Handling, CRA Experience)

Designation Clinical Research Associate

**Responsibilities**:
Participates in the investigator recruitment process.

Performs initial qualification visits of potential investigators.

Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.

Works with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies.

Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
Works with Study Start-up Group and site staff to obtain regulatory (EC) 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.
Conducts periodic site file audits to ensure compliance with GCPs and company’s standard operating procedures.

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 in a timely manner using approved company /sponsor forms 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.
Reviews protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager.

Serves as primary contact between the company and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

Assists with, and attends, Investigator Meetings for assigned studies.
May serve as mentor for new clinical study monitors.

Authorized to request site audits for reasons of validity.

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