Sr Cra I - Sponsor Aligned - Healthy Volunteer Phase I

2-8 years

Not Disclosed

Remote, USA

10 Aug. 16, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Senior Clinical Research Associate I

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into actionable outcomes to meet modern market needs.

Our Clinical Development model places the customer and patient at the heart of all we do. We continuously seek ways to simplify and streamline our work, making Syneos Health easier to collaborate with and work for. Whether in a Functional Service Provider partnership or a Full-Service environment, you'll work alongside passionate problem-solvers, innovating as a team to help our customers achieve their goals. We are driven by agility and a passion for accelerating the delivery of therapies that can change lives.

Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Why Syneos Health?

We are committed to developing our people through career progression, supportive and engaged management, technical and therapeutic area training, peer recognition, and a total rewards program. Our Total Self culture allows you to be your authentic self. We unite globally under this culture, dedicating ourselves to taking care of our people. We are building the company we all want to work for, and our customers want to work with. When we bring together diverse thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels they belong.

Job Responsibilities

Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely) ensuring compliance with regulatory guidelines, ICH-GCP, GPP, and protocols.
Evaluate site and staff performance, making site-specific recommendations, and immediately escalate serious issues to the project team with action plans.
Maintain working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
Verify informed consent process, protecting patient confidentiality, and assessing factors affecting patient safety and clinical data integrity.
Conduct Source Document Review, verify clinical data accuracy, and guide query resolution.
Perform investigational product (IP) inventory and ensure compliance with IP protocols.
Review the Investigator Site File (ISF) for accuracy and ensure compliance with local guidelines for document archiving.
Document activities, support recruitment strategies, and manage site-level activities to meet project objectives and timelines.
Act as a primary liaison with project site personnel and ensure compliance with training and project-specific requirements.
Provide guidance for audit readiness, prepare for audits, and follow up on necessary actions.
Mentor junior CRAs and may lead clinical operations under supervision.

Qualifications

Bachelor's degree or RN in a related field, or equivalent combination of education, training, and experience.
Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
Proficiency with computers and adaptability to new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage travel up to 75% regularly.

Get to Know Syneos Health

In the last five years, we have collaborated with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites with 675,000+ trial patients. No matter your role, you’ll take the initiative and challenge the status quo with us in this highly competitive, ever-changing environment.

Additional Information:

Responsibilities and tasks outlined are not exhaustive. The Company may assign additional duties as needed.
We provide reasonable accommodations for employees and applicants to perform essential job functions as required by law.
Syneos Health has a voluntary COVID-19 vaccination policy. Certain local governments or customers may have vaccine requirements that apply to some employees, requiring proof of vaccination.

Benefits for this position include:

Company car or car allowance
Health benefits (Medical, Dental, Vision)
401k with company match
Employee Stock Purchase Plan eligibility
Bonus/commission based on performance
Flexible PTO and sick time

Salary Range: $72,540 to $145,000 annually, depending on qualifications, skills, and experience.

Apply Now
If you're not ready to apply, join our Talent Network to stay connected with additional career opportunities.

Diversity & Inclusion:
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your experience doesn't align perfectly, we still encourage you to apply. We consider transferable skills from previous roles and encourage you to join our Talent Network for future opportunities.

Latest Jobs

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Kannur | Kochi | Malappuram | Thiruvananthapuram |

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Denver |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Louisville | Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maine :

Bangor | Brewer |

Maryland :

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | United States |

United States :

Hawai | Sylmar |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Latvia | Leuven | Poland | Spain |

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Australia

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Pharma Jobs in United Kingdom

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Surrey :

Pirbright |

Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

Buenos Aires :

Buenos Aires |

Austria :

Austria |

Vienna :

Vienna |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Richmond Hill | Mississauga | North York | Uxbridge |

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

South Yorkshire :

Sheffield |

United Kingdom :

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Chuuk :

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Paris | Lyon |

Attica :

Athens | Koropi |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

Netanya | Kfar Saba | Tel Aviv | Be'Er Sheva |

Italy :

Italy |

Lombardy :

Rho |

Japan :

Japan |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

Midrand |

Brazil :

Sao paulo |

South America :

Argentina |

Catalonia :

Barcelona |

Madrid :

Madrid |

Sweden :

Sweden |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Kyiv Oblast :

Kyiv |

Dubai :

Dubai |

Hà Nội :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Sr Cra I - Sponsor Aligned - Healthy Volunteer Phase I

Job Description

Senior Clinical Research Associate I

Why Syneos Health?

Job Responsibilities

Qualifications

Get to Know Syneos Health

Additional Information:

Latest Jobs

Medical Coder

Hospital Pharmacist

Principal Statistical Programmer

Senior Principal Biostatistician

Associate Director - Pks Drug Disposition, Hyd

Tco Physician

Director - Pks Gh Ta Lead

Medical Director Ii

Clinical Operations Specialist

Analyst, Global Stability