**Please read the Job Description below before applying

Job Title - Clinical Research Associate (CRA)
Level - 1
Reporting to -

- Reports to Manager/Designee - Clinical Operations.
Interacts internally with clinical monitoring team, QA, DM
and externally with Sites, Sponsors
- Reportees - Individual Contributor position
Location - Faridabad/Chennai

The PURPOSE of the position:

- On-site monitoring, coordination of Phase I-IV clinical trials.
- Oversees the progress of clinical monitoring by conducting pre-
study, initiation, interim and close out visits at sites. Monitors
clinical trials in accordance with Good Clinical Practices and
procedures set forth by CliniRx and sponsors. Works closely with
the Clinical Trial / Project Manager to ensure all monitoring
activities are conducted according to study requirements.

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 and CliniRx standard operating procedures
- Assures adherence to Valuable 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
CliniRx/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 between CliniRx and investigator;
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:

- Must have experience in Global Clinical Trials, studies etc
- 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.

Educational Qualifications
Experience -
Graduate Degree in Life Sciences (or equivalent)
A minimum of 2-3 years of on-site clinical monitoring experience

Personal Attributes

- Must possess excellent verbal and written communication,
interpersonal and organizational skills.
- Requires an ability to work independently, prioritize, and
work within a matrix team environment.
- Computer literacy and knowledge of electronic data capture
preferred.
- Must be able to travel domestically and internationally 50-
75% of total time.

Point of Contact - +918116806787(Aaryan Pradhan)

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