Clinical Research Associate

14 hours ago

Navi Mumbai Maharashtra, India OMH HealthEdge Holdings Full time

Vasta Bio-Informatics Private LimitedMAHARASHTRAPosted On
20 Jun 2025
End Date
31 Jul 2025
Required Experience
1 - 3 Years
- Basic Section

No. Of Openings

2

Grade

C1B

Designation

Clinical Research Associate

Closing Date

31 Jul 2025
- Organisational

Country

IN

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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