Overview:
Job Posting Title


India Remote/Ahmedabad/Bengaluru/New Delhi


The Emmes Company, LLC (\xe2\x80\x9cEmmes\xe2\x80\x9d) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.


Our \xe2\x80\x9cCharacter Achieves Results\xe2\x80\x9d culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.


If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee \xe2\x80\x94 from entry level through top executive \xe2\x80\x94 to contribute to our clients\xe2\x80\x99 success by sharing ideas openly and honestly.


Primary Purpose
The Clinical Research Associate (CRA) I is responsible for monitoring clinical study sites either on-site
at investigative sites or remotely to ensure clinical trials are conducted, recorded, and reported in
accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable
regulatory requirements. The CRA will conduct monitoring visits and activities in accordance with
Emmes SOPs, applicable regulations, and ICH GCP.
Responsibilities:
Key Accountabilities/Duties/Responsibilities

• Under the supervision of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead

CRA, Project Manager, etc.), conducts remote and on-site monitoring visits such as
qualification/pre-study visits, site initiation visits, interim/routine monitoring visits, closeout
visits, and for-cause visits.

• As part of the site visits, conducts Informed Consent (ICF) review, source data verification/source

document review, review for compliance with required reporting/tracking of adverse events and
protocol deviations, investigator site file review, laboratory tour and specimen storage
assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location
tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities
per the site monitoring plan under direction from the project CRA staff oversight lead

• Documents observations and monitoring activities in a site visit report at the conclusion of the

visit with assistance and oversight by the project CRA staff oversight lead

• Facilitates and oversees Action Item resolution post visit
• Helps to ensure that clinical sites are conducting the study in compliance with protocol/clinical

investigational plan, SOPs, ICH GCP, and other applicable regulations.

• Provides training and retraining to site staff including protocol, GCP/GDP, and other training under

direction from the project CRA staff oversight lead

• Identifies areas requiring follow-up and improvement at each clinical study site and reports

findings to project CRA staff oversight lead

• Ensures all visits are conducted according to country regulations, ICH GCP, and company standard

operating procedures

• Serves as point of contact for study site personnel to answer questions and resolve study-related

issues under the direction of the project CRA staff oversight lead

• May assist with the development and/or review of study-related materials including protocols,

informed consent forms, monitoring plan, monitoring documents, etc.
CORPORATE CONFIDENTIAL

• Prepares for and attends project team meetings and provides updates on project status and sitespecific performance
• Works collaboratively and effectively in a project team environment including internal and external

colleagues to meet project objectives and timelines

• Participates in Investigator Meetings or other client meetings as needed
• Assists with filing and archiving of study documents
• May assist with coordination of clinical study supplies
• May assist with submission of applications/notifications to Institutional Review Board (IRB)/Ethics

Committee (EC)/Regulatory Authority

• May assist with site recruitment oversight activities such as developing focused patient recruitment

strategies and action plans.

• Performs site management activities as required
• Other duties as assigned

Qualifications:
Required Education and Experience

• Bachelor\xe2\x80\x99s degree (scientific discipline preferred) or equivalent work experience
• At least 1 year of professional experience preferred
• Prior clinical research experience (as a CTA, in-house CRA, CRC etc.) preferred

Required Skills/Abilities

• Proficient with MS Office Suite
• Excellent computer and organizational skills
• High level of attention to detail required
• Ability to work on varying projects and exercise critical thinking
• Self-starter who can work remotely independently and a team player who can work cross

functionally with heavy oversight

• Knowledgeable in clinical research operations, including interpretation and implementation of

country regulations/ICH guidelines, as required

• Excellent organizational, interpersonal, and communication skills (both oral and written)
• Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment
• Knowledgeable in prioritization, problem-solving, organization, critical thinking, decisionmaking, time management, and planning activities
• Ability to collaborate with internal and external colleagues and work well in a team-oriented

setting
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - The Emmes Company, LLC