Location: Fully Remote (UK)
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our approach centers on translating clinical, medical affairs, and commercial insights into actionable outcomes, addressing modern market needs. We aim to simplify and streamline our processes, enhancing both our client and employee experience.
At Syneos Health, our model is designed to keep the customer and patient at the heart of everything we do. We’re committed to fostering a collaborative environment where passionate problem solvers work together to help our customers achieve their goals. Our agile and driven team works to accelerate the delivery of therapies, making a tangible impact on lives.
Site Management: Conduct site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely), ensuring compliance with regulatory requirements, ICH-GCP, GPP, and protocol.
Compliance and Documentation: Verify informed consent processes, protect subject confidentiality, and assess factors affecting safety and data integrity. Ensure compliance with data capture requirements and maintain accurate documentation.
Data Review and Query Resolution: Review source documents, ensure CRF data accuracy, resolve queries, and guide site staff. Support effective data review and capture using available tools.
Investigational Product Oversight: Manage IP inventory, reconciliation, and security. Ensure correct dispensing and administration, and handle blinded or randomized information.
Site and Project Oversight: Regularly review and reconcile Investigator Site Files with Trial Master Files. Track project metrics, budgets, and timelines. Adapt to changing priorities to meet project goals.
Training and Mentorship: Act as a primary liaison with study site personnel, ensuring training and compliance. Provide mentorship and supervision to junior CRAs, and assist with Investigator Meetings and sponsor meetings.
Audit Readiness: Support audit preparation and compliance, ensuring readiness and addressing follow-up actions.
Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Experience: Proven CRA background with several years of experience as a Senior CRA, preferably within the UK, in either a pharmaceutical company or CRO. Oncology experience is essential.
Skills: Strong communication, presentation, and interpersonal skills. Moderate critical thinking abilities required. Ability to manage regular travel (up to 50%).
Regulatory Knowledge: In-depth understanding of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements.
Over the past five years, Syneos Health has collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients. At Syneos Health, you’ll challenge the status quo in a dynamic and competitive environment.
Additional Information: The duties and responsibilities described are not exhaustive. Syneos Health reserves the right to assign additional tasks as necessary. Equivalent experience and qualifications will be considered. This description does not constitute an employment contract. We are committed to complying with all relevant legislation and providing reasonable accommodations in accordance with the Americans with Disabilities Act.
For more information about Syneos Health and career opportunities, visit Syneos Health Careers.
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Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
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Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Dewas | Gwalior | Indore |Maharashtra :
Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata | Mukundapur |Arizona :
Chandler | Tempe | Tucson |California :
Brisbane | Davis | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Mountain View | Nevada | Pasadena | Pleasanton | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | Santa Clara | Santa Monica | Simi Valley | Stanford | West Valley City |Colorado :
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Coral Gables | Gainesville | Jacksonville | Orlando | Rueil-Malmaison | Tallahassee | West Palm Beach |Georgia :
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Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | 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 | West Orange | Westfield | Wharton | Whippany |New York :
Biddle | Buffalo | Ithaca | Morningside Heights | New York | Syracuse |North Caroline :
Chapel Hills | Durham | Morrisville | Raleigh | Scottsdale |Ohio :
Columbus, |Pennsylvania :
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Mexico |Tennessee :
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Blacksburg | Charlottesville | Falls Church |Washington :
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Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Halle |Schleswig Holstein :
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Nedlands |Republic of China :
Beijing |Tokiyo :
Tokyo | Osaka |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Salt Lake City | London |Republic of Ireland :
Limerick | Dublin |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Switzerland | Remote | Remote - Europe | Remote, USA |Makkah :
Khulais | Rabigh | Najran | Riyadh | Jeddah |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |