Clinical Research Associate (Cra) Ii (Remote, Client Based)

3+ years

Not Disclosed

Remote, India, India

Openings: 15 Sept. 8, 2026

Job Description

Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance

Clinical Research Associate (CRA) II – Remote, Client Based

Company: Syneos Health®
Location: Remote, India
Client Location: Mumbai, India
Job ID: 25112019
Updated: September 1, 2026
Job Family: Clinical Monitoring / CRA

About Syneos Health

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. The company partners with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

The Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to understand customer needs and represent those needs in the solutions they shape.

Whether joining a Functional Service Provider partnership or a Full-Service environment, employees collaborate with passionate problem solvers, innovating as a team to help customers achieve their goals.

Syneos Health is agile and driven to deliver for colleagues, customers, and, most importantly, those in need.

Why Syneos Health

Passionate about developing employees through career development and progression.
Supportive and engaged line management.
Technical and therapeutic-area training.
Peer recognition and total rewards programs.
Commitment to an inclusive culture where employees can authentically be themselves.
Purpose-driven culture centered around Driven to Deliver.
Opportunity to work with colleagues globally to shape the future of healthcare.
Focus on driving customer impact and accelerating patient progress.

Position Overview

Role: Clinical Research Associate (CRA) II
Work Arrangement: Remote
Client Based: Mumbai
Minimum Experience: 3 years of onsite monitoring experience
Preferred Therapeutic Experience: 1–2 years of Oncology experience preferred.

Candidates with experience in the following therapeutic areas are also preferred:

Neuroscience
Haematology
Cardiovascular
Rare Disease

Key Job Requirements

Minimum 3 years of onsite monitoring experience.
1–2 years of Oncology experience preferred.
Experience in other relevant therapeutic areas such as Neuroscience, Haematology, Cardiovascular, and Rare Disease is also preferred.
Remote opportunity with Mumbai client-based responsibilities.
Ability to manage regular travel of up to 75%.

Core Clinical Monitoring Responsibilities

Perform site qualification visits.
Perform site initiation visits.
Conduct interim monitoring visits.
Perform site management activities.
Conduct close-out visits.
Visits may be performed either on-site or remotely.
Ensure compliance with:
- Regulatory requirements
- ICH-GCP
- Good Pharmacoepidemiology Practice (GPP), where applicable
- Clinical trial protocol requirements
Use judgment and experience to evaluate the overall performance of sites and site staff.
Provide recommendations regarding site-specific actions.
Immediately communicate or escalate serious issues to the project team.
Develop appropriate action plans for identified issues.
Maintain working knowledge of ICH/GCP guidelines, applicable guidance, relevant regulations, and company SOPs/processes.

Informed Consent & Subject/Patient Safety

Verify that the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required.
Demonstrate diligence in protecting the confidentiality of each subject/patient.
Assess factors that may affect:
- Subject/patient safety
- Clinical data integrity
Identify and assess issues such as:
- Protocol deviations
- Protocol violations
- Pharmacovigilance issues
Ensure appropriate issues are communicated and escalated.

Source Data & Clinical Data Review

As defined by the Clinical Monitoring Plan / Site Management Plan (CMP/SMP):

Assess site processes.
Conduct Source Document Review (SDR) of appropriate site source documents and medical records.
Verify that required clinical data entered into the Case Report Form (CRF) is accurate and complete.
Apply query-resolution techniques both remotely and on-site.
Provide guidance to site staff as necessary.
Drive query resolution to closure within agreed timelines.
Utilize available hardware and software to support effective clinical study data review and capture.
Verify site compliance with electronic data capture requirements.

Investigational Product (IP) Management

Perform Investigational Product (IP) inventory, reconciliation, and storage/security reviews as required.
Verify that IP has been dispensed and administered to subjects/patients according to the protocol.
Verify issues or risks associated with blinded or randomized information related to IP.
Apply knowledge of:
- GCP
- Local regulations
- Organizational procedures
Ensure IP is appropriately:
- Re-labelled
- Imported
- Released
- Returned

Investigator Site File (ISF) & Trial Master File (TMF)

Routinely review the Investigator Site File (ISF) for:
- Accuracy
- Timeliness
- Completeness
Reconcile ISF contents with the Trial Master File (TMF).
Ensure investigator/physician sites are aware of requirements for archiving essential documents.
Ensure archiving is performed in accordance with applicable local guidelines and regulations.

Monitoring Documentation

Document clinical monitoring activities through:

Confirmation letters
Follow-up letters
Trip reports
Communication logs
Other required project documentation

All documentation should be prepared according to:

Company SOPs
Clinical Monitoring Plan (CMP)
Site Management Plan (SMP)
Project-specific requirements

Subject/Patient Recruitment & Retention

Support subject/patient recruitment strategies.
Support subject/patient retention strategies.
Support subject/patient awareness strategies.
Monitor recruitment and retention-related activities as required.
Enter relevant data into tracking systems.

Tracking & Issue Management

Enter data into tracking systems as required.
Track:
- Observations
- Ongoing site status
- Assigned action items
Follow assigned action items through to resolution.
Maintain appropriate documentation and tracking of site activities.

Project Scope, Budget & Timeline Management

For assigned activities:

Understand project scope.
Understand project budgets.
Understand project timelines.
Manage site-level activities and communications.
Ensure project objectives are achieved.
Ensure project deliverables are completed.
Ensure timelines are met.
Adapt quickly to changing priorities.
Work effectively toward project goals and targets.

Site Liaison & Communication

May act as the primary liaison with study site personnel.
May work in collaboration with a Central Monitoring Associate.
Ensure all assigned sites comply with applicable requirements.
Ensure project-specific site team members are appropriately trained.
Ensure assigned sites and site personnel remain compliant throughout the study.

Investigator & Sponsor Meetings

Prepare for and attend Investigator Meetings.
Prepare for and attend sponsor face-to-face meetings.
Participate in global clinical monitoring/project staff meetings.
Participate in meetings involving Sponsor representatives, where applicable.
Attend clinical training sessions according to project-specific requirements.

Audit Readiness

Provide guidance at the site and project level toward audit-readiness standards.
Support preparation for audits.
Support required audit follow-up actions.
Maintain documentation and site processes in an audit-ready state.

Training & Regulatory Compliance

Maintain working knowledge of:
- ICH/GCP Guidelines
- Applicable regulatory guidance
- Relevant regulations
- Company SOPs/processes
Complete assigned training as required.
Ensure ongoing compliance with applicable clinical research and company requirements.

Real World Late Phase Responsibilities

For Real World Late Phase studies, the CRA II may use the business-card title Site Management Associate II (SMA II).

Additional responsibilities may include:

Provide site support throughout the study lifecycle, from site identification through close-out.
Maintain knowledge of local requirements for real-world late-phase study designs.
Perform chart abstraction activities.
Perform data collection.
Collaborate with:
- Sponsor affiliates
- Medical Science Liaisons (MSLs)
- Local country staff
Train junior staff when requested.
Identify and communicate out-of-scope activities to the Lead CRA / Project Manager.
Proactively suggest potential sites based on local knowledge of:
- Treatment patterns
- Patient advocacy organizations
- Healthcare Provider (HCP) associations

Qualifications

Educational Qualification

Bachelor’s degree or RN in a related field; or
Equivalent combination of education, training, and experience.

Clinical Research Experience

Minimum 3 years of onsite monitoring experience in Global Clinical Trials.
Oncology experience of 1–2 years is preferred.
Experience in other therapeutic areas such as Neuroscience, Haematology, Cardiovascular, and Rare Disease is also preferred.

Regulatory Knowledge

Knowledge of:

Good Clinical Practice (GCP)
ICH Guidelines
Applicable regulatory requirements
Clinical trial processes
Site monitoring requirements

Technical Skills

Good computer skills.
Ability and willingness to embrace new technologies.
Ability to use technology effectively for remote and on-site monitoring activities.
Familiarity with clinical trial systems and electronic data capture processes.

Communication & Interpersonal Skills

Excellent communication skills.
Excellent presentation skills.
Excellent interpersonal skills.
Ability to communicate effectively with:
- Site personnel
- Sponsors
- Project teams
- Internal stakeholders
- External stakeholders

Organizational & Travel Requirements

Strong organizational skills.
Ability to manage multiple activities and priorities.
Ability to adapt to changing priorities.
Ability to meet project timelines and targets.
Ability to manage required travel of up to 75% on a regular basis.

Key Skills / ATS Keywords

Clinical Research

Clinical Research Associate
CRA II
Clinical Monitoring
Global Clinical Trials
Site Monitoring
Onsite Monitoring
Remote Monitoring
Site Management
Site Qualification
Site Initiation
Interim Monitoring
Close-Out Visits
Investigator Meetings

Clinical Trial Activities

Source Document Review
Source Data Verification
CRF Review
Query Management
Query Resolution
EDC
Protocol Compliance
Protocol Deviations
Protocol Violations
Informed Consent
Subject Safety
Data Integrity
Patient Recruitment
Patient Retention

Investigational Product

IP Management
IP Inventory
IP Reconciliation
IP Storage
IP Accountability
Blinding
Randomization
IP Dispensing
IP Administration

Documentation

Investigator Site File (ISF)
Trial Master File (TMF)
Essential Documents
Archiving
Trip Reports
Follow-Up Letters
Confirmation Letters
Communication Logs

Regulatory / Compliance

ICH-GCP
GCP
GPP
Regulatory Compliance
Clinical Trial Regulations
SOPs
Audit Readiness
Audit Support

Therapeutic Areas

Preferred experience includes:

Oncology
Neuroscience
Haematology
Cardiovascular
Rare Disease

Real World Late Phase / SMA II

Real World Late Phase Studies
Site Identification
Site Management
Chart Abstraction
Data Collection
Local Regulatory Requirements
Sponsor Collaboration
Medical Science Liaison Collaboration
HCP Associations
Patient Advocacy
Treatment Pattern Knowledge

Core Competencies

Clinical monitoring expertise
Site management
Risk identification
Problem solving
Query resolution
Regulatory compliance
Data quality management
Patient safety awareness
Attention to detail
Communication
Presentation skills
Stakeholder management
Time management
Organization
Adaptability
Technology adoption
Audit readiness

Get to Know Syneos Health

Over the past 5 years, Syneos Health has worked with:

94% of all Novel FDA Approved Drugs
95% of EMA Authorized Products
200+ Studies
73,000 Sites
675,000+ Trial Patients

Syneos Health encourages employees to take initiative and challenge the status quo in a highly competitive and continuously changing environment.

Job Family Summary – Clinical Monitoring / CRA

Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location.

Responsibilities include:

Conducting remote monitoring of trial sites.
Verifying compliance with regulatory requirements.
Verifying compliance with clinical protocols.
Using data analytics to identify potential issues and trends.
Applying risk-based monitoring techniques.
Ensuring trials are conducted according to established clinical practices.
Collaborating with site teams.
Developing and implementing tools, procedures, and processes that enhance quality monitoring.
Supporting the overall success of clinical trials.

Impact & Contribution

The role is an individual contributor position with responsibility in a professional or technical discipline or specialty.

The role may involve:

Managing two or fewer employees.
Directing the work of lower-level professionals.
Managing processes and programs.
Contributing to the design, implementation, or delivery of processes, programs, and policies.
Applying knowledge and skills typically acquired through advanced education.

This is an established and productive individual contributor role.

The position may involve:

Managing defined components of projects or processes within the area of responsibility.
Applying practical knowledge of a professional area.
Using knowledge acquired through education combined with professional experience.

Additional Information

The tasks, duties, and responsibilities listed in this job description are not exhaustive.

Syneos Health, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and/or education will also be considered, so qualifications of incumbents may differ from those listed in the Job Description.

The Company, at its sole discretion, will determine what constitutes equivalent qualifications.

Nothing contained herein should be construed to create an employment contract.

Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which Syneos Health operates, including the implementation of the EU Equality Directive, in relation to recruitment and employment.

Syneos Health is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants in performing the essential functions of the job.

Application

Apply for this job

Candidates who are not ready to apply can join the Syneos Health Talent Network to stay connected to additional career opportunities.

Recently Viewed Jobs

Safety & PV Specialist I – Literature Review
Safety & PV Coordinator

Company

Syneos Health®

Recommended Jobs

Pharma Jobs in India

Uttar Pradesh :

Gujarat :

Maharashtra :

Haryana :

Punjab :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | Gangtok | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Remote, India | Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Arkansas :

Fort Smith |

Kington :

Frank Scottile Blvd |

Missouri :

Fulton | Milan | St. Louis |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Nebraska :

Hebron | Nebraska City |

Hawaii :

Hilo | Honolulu |

Tennessee :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

Lisbon | Oeiras | Portugal |

WI :

Madison | Wausau |

Republic of Mexico :

Mexico |

northeastern :

New Hampshire |

Oklahoma :

Oklahoma City |

Puerto Rico :

San Juan |

Albama :

Tuscaloosa |

D.C :

Washington |

Delaware :

Wilmington |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Germany :

Germany | GErmany |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Saxony Anhalt :

Halle |

Rotherbaum :

Hamburg |

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Schleswig Holstein :

Kiel |

Berlin :

Mitte |

Mecklenburg Vorpommern :

Rostock |

Saarland :

Saarbrucken |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

Tipperary :

Ballydine |

Cork :

Brinny | Ringaskiddy |

Carlow :

Carlow |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Meath :

Dunboyne |

Dún Laoghaire :

Dún Laoghaire |

Galway :

Galway |

County Dublin :

Swords |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

Pharma Jobs in Other Countries

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Peru | Argentina |

Brazil :

Sao paulo | Brazil |

Attica :

Athens | Koropi |

Greece :

Greece |

North Island :

Auckland |

New Zealand :

New Zealand |

Austria :

Austria |

Vienna :

Vienna |

Catalonia :

Barcelona |

Madrid :

Madrid |

Cebu Province :

Cebu City |

Philippines :

Manila |

Croatia :

Croatia |

Zagreb :

Zagreb |

Estonia :

Tartu | Estonia |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hanoi | Hà Nội |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Japan | Saitama |

Tokyo :

Otemachi |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

New Mexico | Ciudad de México |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Paris | Lyon |

South Africa :

Midrand | South Africa |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Clinical Research Associate (Cra) Ii (Remote, Client Based)

Job Description

Recommended Jobs

Clinical Data Specialist

Clinical Data Specialist

Senior Clinical Data Team Lead

Title: Clinical Research Associate - Chennai

Title: Lead - Clinical Nutrition

Clinical Data Management

Clinical Data Svs Associate

Clinical Data Svs Associate

Clinical Data Coordinator Ii

Associate Director - Clinical Research Lead

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Ireland

Pharma Jobs in China

Pharma Jobs in Netherland

Pharma Jobs in Australia

Pharma Jobs in United Kingdom

Pharma Jobs in England

Pharma Jobs in Other Countries

Trainings

Pages

Find

Welcome Back

Create Account

Clinical Research Associate (Cra) Ii (Remote, Client Based)

Job Description

Recommended Jobs

Clinical Data Specialist

Clinical Data Specialist

Senior Clinical Data Team Lead

Title: Clinical Research Associate - Chennai

Title: Lead - Clinical Nutrition

Clinical Data Management

Clinical Data Svs Associate

Clinical Data Svs Associate

Clinical Data Coordinator Ii

Associate Director - Clinical Research Lead

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Ireland

Pharma Jobs in China

Pharma Jobs in Netherland

Pharma Jobs in Australia

Pharma Jobs in United Kingdom

Pharma Jobs in England

Pharma Jobs in Other Countries