Progroup India Hiring for Required Freshers Immediately Clinical Research/Pv/CDM/RA at Bengaluru, Karnataka Full Time

Key Skills r r

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Interaction with Patients, Sponsor/CRO, IEC, Lab staff and other departments in the institution and conduct the study according to ICH GCP Guidelines, SOPs and study protocol guidelines and act as the main line of communication between patients, Investigators and CROs in study conduct activitiesr

Assist in Feasibility questionnaires, Coordinate in pre-site selection visit, site initiation visit.r

Assist the Principle Investigator and Co investigators in screening of subjects by maintaining and updating the list of potentially eligible patients for the ongoing studiesr

r r Core Responsibilities : r r

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Coordinate in screening, Audio-Video consenting, enrolment, periodic study visits and close out visit.r

Ensure that rights and well-being of a research participant is protected throughout the duration of the study.r

Coordinate with finance, legal and regulatory team and assist in the preparation of CTAs specific to the trialsr

Assure all study documentation is maintained by completing the source documents for eachr

Patient and maintaining and updating Site Master Filesr

Completing CRFs, e-CRFs on time and resolve data queries.r

EDC, InForm Medios data capturer

Ensure and maintain inventory of Study consumables like Investigational product handling, storage, dispensing, accountability, tracking temperature, calibration of equipment s, sample centrifugation, courier of documents and lab samples shipmentr

Timely preparation, notification and tracking of the Ethics committee submissionsr

Submission of the study progress, amendments, Protocol Deviations, AEs and SAEs to the ethics committee and sponsor in a timely mannerr

Coordinate with the investigator and the safety monitoring team at the time of SAEsr

Assist in resolving IEC, DCGI and FDA queriesr

Coordinate and participate in monitoring visits with sponsor/CRO and Facilitating inspections/auditsr

Follow up with patients and document in telephone contact reportr

Conduct study closeout visit and archive the documentsr

Maintain record of closeout studies and resolve the post closeout queriesr

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Ward round participation to evaluate potential patients with indications for screening into clinical trials.r

Maintain registry for Hemophilia A, Hemophilia B, Afibrinogenemia, Aplastic Anemia.r

Distribution of Factors for patients in need from World Hemophilia Federation (India).r

Follow IEC protocols accuratelyr

r r Regards,r r Pavithra Rr r (Hr Executive)

Education: Any Graduate

Industry: Biotechnology/Pharmaceutical/Medicine, Healthcare

Skills Required

Medical Coding Clinical Research Clinical Trial Ich Pharmacovigilance Gcp

Job Detail

Job Id

JD2539840

Industry

Not mentioned

Total Positions

1

Job Type:
Full Time

Salary:
Not mentioned

Employment Status

Permanent

Job Location

Bengaluru/ Bangalore (Karnataka), Chennai (Tamil Nadu), Hyderabad/ Secunderabad (Andhra Pradesh), Pu,

Education

Not mentioned

Experience

0 to 3 Year