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OMH HealthEdge Holdings
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Clinical Research Associate

Clinical Research Associate

OMH HealthEdge Holdings

1 - 3 years

0 Lacs

Navi Mumbai

Posted:1 month ago| Platform: GlassDoor logo

Apply

Skills Required

research pharmacovigilance writing oncology development gcp data management reporting documentation report database tracking compliance consistency monitoring certification medidata oracle communication

Work Mode

Remote

Job Type

Part Time

Job Description

Vasta Bio-Informatics Private LimitedMAHARASHTRA

Posted On

20 Jun 2025

End Date

31 Jul 2025

Required Experience

1 - 3 Years

Basic Section

No. Of Openings

Grade

C1B

Designation

Clinical Research Associate

Closing Date

31 Jul 2025

Organisational

Country

State

MAHARASHTRA

City

NAVI MUMBAI

Location

Navi Mumbai-I

Skills

Skill

PHARMACOVIGILANCE

CLINICAL RESEARCH

MEDICAL WRITING

ONCOLOGY

CLINICAL DEVELOPMENT

CRO

GCP

EDC

CLINICAL DATA MANAGEMENT

ICH-GCP

Education Qualification

No data available

CERTIFICATION

No data available

Job Description

Job Title: Clinical Research Associate

Department: Delivery

Job Location: Navi Mumbai

Reporting To: Lead

Job Duties / Responsibilities:

Project and Operations Management-

Responsible for the management of designated clinical trials, preparation of trial related documentation per protocol and Case report forms (CRF).
Ensure completeness and submission of data into the data collection form (e.g., electronic CRFs, cancer research database (CRDB), PC-based systems, remote data entry) as per protocol requirements and time lines.
Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion and in compliance with ICH-GCP guidelines.
Ensure the conduct of the trial is in compliance with the currently approved protocol/amendment.
To significantly improve quality assurance and consistency in electronic data capturing and data.
Participate in global conference calls and meetings to review progress of ongoing clinical trials.
Proficient in the knowledge of protocol monitoring activities.
Verify that the investigator followed the approved protocol and all GCP procedures.
Communicate any observations to the sponsor i.e. deviations/violations to protocol, safety alerts, quality issues, etc. that may affect the quality of the protocol.
Complete regulatory requirements, as applicable.

Education and Experience:

Bachelors/ Masters Degree with minimum 1 year experience in Clinical Trials Management/Protocols or 0-6 months of experience in Clinical Trials along with certification in Clinical Trials / Research.
Knowledge of Oncology Specific terminology preferred.
Knowledge of EDCs such as Medidata RAVE, Oracle, Inform, etc. strongly preferred.
Experience with Industrial protocols and monitoring visits strongly preferred.
Hands-on with computer skills
Good communication skills – written and verbal
Ability to multitask, work under pressure and meet deadlines required

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