Location: Remote (USA)
Company Overview
Syneos Health® is a premier fully integrated biopharmaceutical solutions organization dedicated to accelerating success for our customers. We leverage unique clinical, medical affairs, and commercial insights to deliver impactful outcomes and address today’s market needs. Our Clinical Development model places the customer and patient at the heart of our work, striving to streamline our processes to make Syneos Health an outstanding partner and employer.
Joining Syneos Health means collaborating with passionate professionals in a dynamic, agile environment focused on delivering therapies efficiently and effectively. With over 29,000 employees across 110 countries, we are committed to making a difference in lives globally.
Site Management: Perform site qualification, initiation, interim monitoring, and close-out visits (both on-site and remotely) to ensure compliance with regulatory requirements, ICH-GCP, GPP, and protocol. Evaluate site performance, address serious issues promptly, and develop action plans as needed. Maintain up-to-date knowledge of applicable guidelines, regulations, and SOPs.
Informed Consent and Confidentiality: Ensure informed consent processes are properly conducted and documented, protect subject confidentiality, and assess safety and data integrity at the site, including protocol deviations and pharmacovigilance issues.
Data Management: Conduct Source Document Reviews, verify accuracy and completeness of clinical data entered into case report forms (CRFs), and apply query resolution techniques both remotely and on-site. Ensure compliance with electronic data capture requirements.
Investigational Product (IP) Oversight: Manage IP inventory, reconciliation, storage, and security. Verify IP dispensation and administration according to the protocol, and handle issues related to blinded or randomized information.
Documentation and Tracking: Review and reconcile Investigator Site Files (ISF) with Trial Master Files (TMF), ensure proper archiving of essential documents, and document activities through various project documents. Support subject recruitment, retention, and awareness strategies, and track observations and action items.
Project Management: Understand project scope, budgets, and timelines, and manage site-level activities to ensure project objectives and deliverables are met. Adapt quickly to changing priorities.
Training and Liaison: Act as the primary liaison with site personnel, ensuring training and compliance. Prepare for and attend Investigator Meetings and sponsor meetings. Provide guidance on audit readiness and support preparation and follow-up actions.
Real World Late Phase (if applicable): Support site management throughout the study lifecycle, including chart abstraction and data collection. Collaborate with sponsor affiliates, medical science liaisons, and local country staff. Train junior staff and identify out-of-scope activities.
Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Experience: Solid background as a CRA with relevant experience, particularly in oncology. Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other regulatory requirements is essential.
Skills: Strong communication, presentation, and interpersonal skills. Proficiency in computer skills and adaptability to new technologies. Ability to manage travel requirements (up to 75%).
COVID-19 Policy: Syneos Health encourages employees to be fully vaccinated. Certain locations or customers may have specific vaccine requirements.
Compensation and Benefits: The annual base salary ranges from $63,090 to $126,100, dependent on qualifications and experience. Benefits include a company car or allowance, health benefits (medical, dental, vision), 401k matching, Employee Stock Purchase Plan eligibility, performance-based bonuses, and flexible PTO.
Legal Compliance: Syneos Health complies with all applicable federal, state, and municipal regulations, including those related to paid sick time.
Join us at Syneos Health and be part of a team where your work makes a global impact. For more information, 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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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 | Khandwa | Khargone | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | 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 :
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Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |California :
Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |Colorado :
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Minneapolis and St. Paul, Minnesota. |Missouri :
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Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | 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 | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |North Carolina :
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Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |Ohio :
Columbus, |Oregon :
Bend | Corvallis | Eugene | Roseburg | Springfield |Pennsylvania :
Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |Portugal :
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Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Netanya | Kfar Saba | Tel Aviv |Republic of Korea :
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Haarlem |Remote :
Remote - Europe | Switzerland | Remote, USA | Remote |Makkah :
Jeddah | Najran | Rabigh | Riyadh | Khulais |Catalonia :
Barcelona |Republic of Thailand :
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