Clinical Research Associate

WOW Softech; India; Remote; INR 700,000 - 1,200,000; Full time

Job summary

WOW Softech is seeking a Clinical Research Associate to participate in investigator recruitment, site qualification, and monitoring activities across multiple trials. You will review protocols and regulatory documents, coordinate with the Start-up Group, and train site staff on eCRFs and the EDC system.

You will ensure regulatory compliance, perform site audits, and support data quality through site coordination and monitoring visits across domestic and international sites.

Qualifications

• Experience in clinical research processes and medical terminology.
• Excellent written and verbal communication skills.
• Strong organizational and interpersonal abilities.
• Ability to interact with staff at all levels to coordinate activities.
• Ability to handle multiple priorities in complex clinical trials.
• Ability to reason independently and propose solutions in clinical settings.
• Able to mentor other CRAs on the project team.
• Understanding of data processing basics and electronic data capture.
• Knowledge of current GCP/ICH guidelines for clinical research.
• Willingness to travel domestically and internationally.

Responsibilities

• Participates in investigator recruitment and qualification visits.
• Evaluates site capability to manage and conduct the study clinically and technically.
• Reviews protocols, eCRFs, study manuals and other documents as requested by Clinical Trial Manager.
• Coordinates with the Study Start-up Group to prepare sites for initiation.
• Obtains and reviews regulatory documentation for study implementation and monitoring.
• Assists in obtaining IRB/IEC approvals for study documents.
• Performs study initiation activities and trains site personnel on protocol, procedures, and eCRF completion.
• Trains site staff on the EDC system and verifies the computer system.
• Conducts periodic site file audits to ensure GCP compliance.
• Ensures adherence to GCP/ICH and company SOPs through on-site monitoring.
• Prepares monitoring reports and sponsor-required documents.
• Documents accountability, storage conditions and inventory of investigational products.
• Performs data query resolution with study sites.
• Acts as primary contact and coordinates all correspondence with sites and for reporting.
• Attends Investigator Meetings and supports close-out visits.
• Aids mentor responsibilities and supports junior CRAs on the project.
• Has authority to request site audits for validity.
• Performs other duties as requested.

Skills

Clinical research processes

Medical terminology

Written and verbal communication

Organizational skills

Interpersonal skills

Coordination with stakeholders

Mentoring junior CRAs

Data processing basics

GCP/ICH knowledge

Travel willingness

Job description

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:

• Strong 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.