Job Title: Clinical Research Associate (CRA)
Locations: Europe, Middle East, Africa, Latin America & Asia Pacific (specific country not listed)
Employment Type: Regular / Full-time
Requisition ID: R363606
Job Posting End Date: 31/10/2025
Company Overview
Merck & Co., Inc., Rahway, NJ, USA (also known as Merck Sharp & Dohme LLC) is a global biopharmaceutical company focused on advancing healthcare through innovative research and clinical development.
Note for Search Firms:
Unsolicited CVs without a valid written search agreement will be considered company property.
No fee will be paid for hires resulting from unsolicited referrals.
Role Overview
The CRA is accountable for performance, compliance, and site management for assigned clinical study protocols in a country. Reporting to the CRA-Manager, the CRA ensures adherence to ICH/GCP, local regulations, company policies, quality standards, and adverse event reporting requirements. The CRA acts as the primary site contact and develops strong site relationships while expanding clinical research capabilities.
Key Responsibilities
Develop and maintain strong relationships with study sites throughout all trial phases.
Conduct clinical study site management/monitoring in compliance with ICH-GCP, Sponsor SOPs, local laws, protocol, and site monitoring plans.
Gain in-depth understanding of study protocols and related procedures.
Coordinate with sponsor roles to achieve Site Ready status.
Participate in site selection and validation activities.
Perform on-site and remote monitoring, ensuring:
Accurate, complete, and unbiased site data
Protection of subjects’ rights, safety, and well-being
Conduct site visits: validation, initiation, monitoring, and close-out. Document visit and non-visit interactions accurately and timely.
Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.
Communicate with investigators and site staff on protocol conduct, recruitment, retention, deviations, audits, and site performance.
Identify, assess, and resolve site performance, quality, or compliance issues; escalate per CRA Escalation Pathway.
Collaborate with GCTO operations, finance, regulatory affairs, pharmacovigilance, legal, vendors, IRBs/IECs, and regulatory authorities.
Maintain documentation in CTMS, eTMF, and other relevant systems.
Act as process Subject Matter Expert (SME), mentor, and share best practices.
Support or lead audits/inspections as needed.
Perform co-monitoring visits as required.
Contribute to identification and development of new potential sites in line with country strategy.
Qualifications & Experience
Education:
Associate's degree / certificate in scientific/healthcare discipline + ≥5 years healthcare experience (≥2 years direct site management in bio/pharma/CRO)
OR
Bachelor’s degree or higher + ≥2 years direct site management experience in bio/pharma/CRO
Core Competencies:
Fluent in local language(s) and English (verbal and written)
Strong knowledge of clinical research, trial phases, ICH/GCP, local and global clinical research guidelines
Hands-on knowledge of Good Documentation Practices
Proven site management skills, including site performance and patient recruitment
Strong analytical skills for data interpretation and decision-making
IT proficiency: MS Office and various clinical IT applications (computer, tablet, mobile)
Root cause analysis and implementation of corrective/preventive actions
Behavioral Competencies:
Effective time management, organizational, and interpersonal skills
Independent judgment and problem-solving
Ability to manage multiple protocols, sites, and therapy areas simultaneously
Accountability, urgency, and priority-setting skills
Positive and growth mindset, professional demeanor
Works effectively in a multicultural matrix environment
Commitment to customer focus, high-quality work, and compliance
Skills Required
Accountability, Adaptability, Adverse Event Reporting Systems
Clinical Research Coordination and Methods
Clinical Study Management and Monitoring
Protocol Adherence, Regulatory Compliance
Data Analysis and Reporting
Training Team Members
Good Clinical Data Management Practice (GCDMP), GCP
Preferred Skills: Not specified
Travel & Relocation
Not specified
Flexible work arrangements: Not applicable
VISA sponsorship: Not specified
Additional Notes
Valid driving license and handling of hazardous materials: Not specified
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
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Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Madhya Pradesh :
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Delhi | India | New Delhi | PAN-India |Assam :
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Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | St. Helena | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Nedlands |Queensland :
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Tallinn |Hà Nội :
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Bangkok |Israel :
Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
Springville | Belgium | Xzagreb | Slovakia | Bountiful | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Castlebar | Lenexa | Leinster | Nairobi | Riga | McFarland | Remote - Europe | Lousiana | Ireland | Green Way | Texas | Faridabad | Blue Bell | Remote, USA | Switzerland | Manipal | Medan | Tulsa | French | Victoria | Zaragoza | Remote - South America (Latin Americal) | Minnesota | Hungary | Remote - Africa | Melbourne | Remote - Middle East | Thailand | Remote | Hammond |Republic of Colombia :
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New Mexico | Ciudad de México |Dubai :
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Rabigh | Jeddah | Najran | King Abdullah Economic City | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
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