Bio-Prospera Clinical Research is a leading Global Contract Research Organization(CRO) based in Mumbai Maharashtra India. We are end to end clinical trials service provider supporting comprehensive drug development and product lifecycle management. Our Clients and partners include pharmaceutical, biotechnology, medical device and government organizations
We are Hiring !!!
Walkin Drive for Vasai, Palghar Location
Walk in Drive Location – Bio Prospera Clinical Research
Venue: Plot 44, Viraj Industrial Estate Gokhiware Village, Chinchpada, Golani Naka, Vasai East, Palghar
Date – 27 August to 29 August
Time – 10am to1pm
Position –
1.Clinical Research Associate
2.Clinical Operation Manager
Eligibility – Life science graduate/B. Pharm/M. Pharm
Experience – 1+ years
Work from office.
Responsibilities
1) Participates in the investigator recruitment process. Performs site initial visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.
2) Works with the study start-up 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 site staff to obtain regulatory (EC) approval of study specific documents.
3) 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.
4) Trains site staff on the EDC system and verifies site computer system.
5) Conducts periodic site file audits to ensure compliance with GCPs and company’s standard operating procedures.
6) Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Time management skill related to travelling. 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.
7) 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.
8) 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 queries.
9) Reviews protocols, eCRF, study manuals and other related documents, as requested by Clinical Trial Manager.
10) 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.
11) Assists with final data review and query resolution through database lock.
Performs study close-out visits.
12) Assists and attends, Investigator Meetings for assigned studies.
13) Authorized to request site audits for reasons of validity
