Clinical Research Associate

3 months ago

Navi Mumbai Maharashtra, India OMH HealthEdge Holdings Full time

Vasta Bio-Informatics Private LimitedMaharashtraPosted On
- 04 Oct 2024
- Required Experience
- 1 - 3 Years
Basic SectionNo. Of Openings

1

Grade

C1B

Designation

CLINICAL RESEARCH ASSOCIATE

Closing Date

29 Nov 2024
- OrganisationalCountry

IN

State

MAHARASHTRA

City

NAVI MUMBAI

Location

Navi Mumbai-I
- SkillsSkill

CLINICAL RESEARCH

ICH-GCP

GCP

CRO

CLINICAL MONITORING

REGULATORY AFFAIRS

Education Qualification

No data available

CERTIFICATION

No data available
- Job DescriptionJob 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.

Security responsibilities
- All Operations staff should never share password to anyone.
- All Operations staff need to ensure systems are locked when not in use.
- All Operations staff must make no PHI data is saved on Vasta domain.

Education and Experience:

- Bachelors/ Masters Degree with minimum 1 year experience in Clinical Trials Management/Protocols or 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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