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

- Assists in the review of protocols, eCRFs, study manuals,

and other study documents as requested by Clinical Trial

Manager

- Works with the Study Start-up Group to coordinate activities

with the site in preparation for the initiation of studies.

Obtains and reviews regulatory documentation for successful

implementation, monitoring, and evaluation of clinical trials.

Works with Study Start-up Group and site staff to obtain

regulatory (IRB/IEC) 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 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

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.

- Reviews the quality and integrity of the clinical data through

in house review of eCRF data and on-site source verification.

- Works with sites to resolve data queries
- Serves as primary contact,coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested
- Assists with, attends, and may present at Investigator

Meetings for assigned studies

- Performs study close-out visits
- Serves as mentor for more junior CRAs as well as new

CRAs to the project

- Authorized to request site audits for reasons of validity
- Performs other duties as requested.

KNOWLEDGE, SKILLS AND ABILITIES:

- Robust knowledge of clinical research process and medical

terminology.

- Excellent written and verbal communication skills to express

complex ideas to study personnel at research and clinical

institutions.

- Excellent organizational and interpersonal skills.
- Ability to interact with all levels of staff to

coordinate/execute study activities.

- Ability to handle several priorities within multiple, complex

clinical trials.

- Ability to reason independently and recommend specific

solutions in clinical settings.

- Able to mentor other CRAs on project team and co-monitor

as required.

- Understanding of basic data processing functions, including

electronic data capture.

- Understanding of current GCP/ICH guidelines applicable to

the conduct of clinical research.

- Ability to travel domestically and internationally.

📌 Clinical Research Associate (Faridabad)
🏢 WOW Softech
📍 Faridabad