Designation – Clinical Research Coordinator
Location – Thane Mumbai (Western line)
1.      Education : B Pharm/M Pharm

2.      Salary : Hike on current salary

3.      Experience: 1-2 Years

§  Fresher :18-25K (Depends on Interview and Knowledge)

§  Experience: 20-25% hike on current salary

IF

Clinical Research Coordinator

§  Fresher :13-20K (Depends on Interview and Knowledge)

§  Experience: 20-25% hike on current salary

Job 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.

2
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 final data review and query resolution through database
lock.
Performs study close-out visits.
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.

#customerresearchassociate #researchassociate #mumbaijob #mumbaijobs 

 Interested candidates kindly forward your updated CV on hr5@tasolutions.in given mail ID with your current and expected CTC or call on 9569909808 if not interested we will really appreciate it if u forward this position to your friends.