Sr Cra I (Estonia) - Sponsor-Dedicated

Syneos Health

2+ years

Not Disclosed

Estonia

10 Nov. 23, 2024

Job Description

Job Type: Remote Education: RN/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Clinical Research Associate I (Estonia, Single-Sponsor)

Company: Syneos Health®

Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, committed to accelerating customer success by translating unique clinical, medical affairs, and commercial insights into real-world outcomes. We focus on putting the customer and patient at the center of everything we do, continuously striving to simplify and streamline our work processes. With a global workforce of over 29,000 employees across 110 countries, we are agile and driven by a passion to change lives.

Why Syneos Health

Employee Development: We emphasize career growth through training, progression, and recognition, alongside a comprehensive rewards program.
Inclusive Culture: Our Total Self culture celebrates authenticity and diversity, making Syneos Health a place where all employees can feel supported and included.
Global Impact: We are building a company that values diverse thoughts and perspectives, enabling us to create a meaningful impact for our customers and communities.

Job Responsibilities

Site Management and Monitoring

Site Qualification & Monitoring: Perform site qualification, initiation, interim monitoring, and close-out visits, ensuring compliance with regulatory standards (ICH-GCP, Good Pharmacoepidemiology Practice) and study protocols.
Risk Assessment and Issue Resolution: Use judgment and experience to evaluate site performance and communicate/escalate issues to the project team. Develop action plans and resolve issues in a timely manner.
Informed Consent: Ensure proper informed consent process is followed and documented for all study subjects, safeguarding patient confidentiality and data integrity.
Clinical Data Management:
- Review and verify the accuracy of clinical data entered in case report forms (CRFs) and site source documents.
- Utilize query resolution techniques and provide guidance to site staff to ensure data integrity.
- Monitor compliance with electronic data capture systems.

Investigational Product (IP) Management

Inventory & Compliance: Perform investigational product inventory and reconciliation. Ensure IP is stored, dispensed, and administered per the protocol.
Blinded Information & Regulatory Compliance: Ensure proper labeling, importation, and release of IP in compliance with local regulations.

Site File Management

Investigator Site File (ISF) Review: Routinely review ISF for completeness and accuracy. Reconcile ISF contents with the Trial Master File (TMF).
Document Archiving: Ensure sites comply with regulatory guidelines for document archiving.

Project Coordination & Support

Project Scope & Timeline Management: Understand project scope, budgets, and timelines. Manage site-level activities and communication to ensure project objectives are met.
Training & Compliance: Ensure that site staff is trained on study requirements. Act as primary liaison between project team and site personnel.
Audit Readiness: Provide guidance to sites and project teams to ensure audit readiness and assist with preparation and follow-up actions.

Real World Late Phase (RWLP)

Site Lifecycle Support: Manage site activities from site identification through close-out for Real World Late Phase studies.
Local Knowledge: Provide insights into local treatment patterns, patient advocacy, and Health Care Provider (HCP) associations to identify and suggest potential sites.
Collaboration: Work with sponsors, affiliates, medical science liaisons, and local country staff to support data collection and chart abstraction activities.
Regulatory Compliance: Collaborate with RWLP regulatory teams to ensure up-to-date regulatory information is applied.
Training & Mentorship: Train junior CRA staff and lead site training initiatives.

Other Responsibilities

Bid Defense: Participate in bid defense meetings and provide input on project proposals.
Process Improvement: Identify and suggest operational efficiencies and process improvements for site management and clinical monitoring.

Qualifications

Education and Experience

Education: Bachelor’s degree or Registered Nurse (RN) in a related field, or an equivalent combination of education, training, and experience.
Experience:
- In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and other applicable regulatory requirements.
- Strong understanding of clinical research processes and site management.
- Proven ability to manage multiple sites and projects effectively.

Skills and Competencies

Technical Skills: Proficiency with clinical data management systems, electronic data capture, and relevant software.
Communication Skills: Excellent verbal and written communication skills, with the ability to engage stakeholders at all levels.
Critical Thinking: Ability to apply basic critical thinking skills to solve problems and address issues effectively.
Travel: Ability to manage required travel of up to 75% regularly.

Additional Information

The duties outlined in this job description are not exhaustive and may evolve as required by the company.
Syneos Health may assign other responsibilities at its discretion.
Equivalent experience, skills, or education may be considered in lieu of the listed qualifications.
Syneos Health is committed to compliance with the Americans with Disabilities Act and providing reasonable accommodations when necessary.

About Syneos Health

Over the past 5 years, Syneos Health has partnered with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites, involving over 675,000 trial patients. Join Syneos Health and make a meaningful impact on global healthcare.

Recommended Jobs

Clinical Research Associate Ii / Sr Cra - Full Service - (Home-Based In Central Us) (Open)

Syneos Health

Remote United States

Sr. Ep Field Clinical Specialist - Central/Western Us

Abbott

Remote United States

Cra (Level Ii)

Thermo Fisher Scientific

India Remote

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

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 Canada & Belgium & South America & Greece & New Zealand & Austria & Spain & Philippines & Croatia & Estonia & Vietnam & Italy & Indonesia & Japan & Finland & Korea & Kazakhstan & Thailand & Israel & Remote & Colombia & Tennessee & Romania & Argentina & Egypt & Mexico & United Arab Emirates & Saudi Arabia & malaysia & Ukraine & Peru & France & South Afrcia & Serbia & Czechia & Chile & Bosnia and Herzegovina & Singapore & Bulgaria & Sweden & Taiwan & Poland

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Argentina | Peru |

Brazil :

Brazil | Sao paulo |

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 :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hà Nội | Hanoi |

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 :

Lyon | Paris |

South Africa :

South Africa | Midrand |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Sr Cra I (Estonia) - Sponsor-Dedicated

Job Description

Job Title: Senior Clinical Research Associate I (Estonia, Single-Sponsor)

Company Overview

Why Syneos Health

Job Responsibilities

Site Management and Monitoring

Investigational Product (IP) Management

Site File Management

Project Coordination & Support

Real World Late Phase (RWLP)

Other Responsibilities

Qualifications

Education and Experience

Skills and Competencies

Additional Information

About Syneos Health

Recommended Jobs

Sr. Regulatory Affairs Specialist

Cra (Level Ii)

Sr Programmer Analyst (Pv Systems)

Cra (Level I, Level Ii And Sr Cra)

Sr. Cdm Programmer (Edc)

Cra Ii - Sponsor Dedicated - Oncology + Gen Med (Home-Based, Eastern Us)

Cra Ii - Sponsor Dedicated - Oncology + Gen Med (Home-Based, Eastern Us)

Clinical Research Associate Ii / Sr Cra - Full Service - (Home-Based In Central Us) (Open)

Sr. Ep Field Clinical Specialist - Central/Western Us

Cra (Level Ii)

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