Live Support, Clinical Research Operations Specialist Ii (React)

Stanford School Of Medicine

2+ years

Not Disclosed

Remote, USA

10 Sept. 17, 2024

Job Description

Job Type: Remote 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

Job Title: Clinical Research Operations Specialist II
Location: Remote
Department: Stanford Center for Clinical Research (SCCR), Department of Medicine
Salary Range: $59,000 - $82,000 per annum (based on location)

About Us:
The Stanford Center for Clinical Research (SCCR) is a dynamic academic research organization within the Stanford Department of Medicine, dedicated to conducting and promoting high-impact, innovative clinical research to advance human health.

Role Overview:
We are seeking a Clinical Research Operations Specialist II to lead and manage a large multi-site clinical trial in cardiovascular medicine. In this role, you will be the primary contact for study sites, the study sponsor, and the principal investigator (PI), providing essential support and managing both virtual and in-person site operations.

Key Responsibilities:

Site Management: Provide live support to study sites for time-sensitive requests and manage overall site operations.
Participant Recruitment and Retention: Oversee recruitment and enrollment goals, and develop strategies to engage and retain participants in long-term trials.
Data Management: Develop and manage systems for data collection, organization, and reporting. Analyze and interpret data as needed.
Project Oversight: Create project schedules, targets, and accountabilities. Lead team meetings and prepare/approve meeting minutes.
Staff Supervision: Supervise, train, and mentor new staff or students. Handle hiring and performance evaluations as required.
Compliance and Audits: Audit operations to ensure regulatory compliance, including laboratory procedures. Monitor and respond to Institutional Review Board (IRB) submissions and queries.
Collaboration: Work closely with principal investigators and study sponsors to monitor and report serious adverse events and resolve study queries.
Process Improvement: Recommend and implement improvements to policies and processes. Define and promote best practices.
Budget Management: Develop study budgets, track milestones, and manage invoicing for sponsors according to study contracts.
Regulatory Compliance: Ensure adherence to regulatory requirements, including Investigational New Drug (IND) applications and IRB renewals.

Desired Qualifications:

Education: Bachelor’s degree in Clinical Research, Public Health, Business, or a related field.
Experience: 2 years in project management and clinical research, with a demonstrated ability to write manuals, present to stakeholders, and develop budgets.
Certifications: Clinical research certification from ACRP, SOCRA, or Stanford’s CROP is preferred.
Skills: Excellent communication, writing, and leadership skills. Proficiency in Microsoft Office and database applications. Knowledge of clinical research protocols, HIPAA, FDA regulations, and Good Clinical Practices.

Required Qualifications:

Education: Bachelor’s degree in a related field and two years of clinical research experience, or equivalent combination of education and relevant experience.
Knowledge and Skills: Strong interpersonal skills, proficiency in data management, and familiarity with medical terminology. Ability to supervise and mentor staff.

Physical Requirements:

Frequent standing, walking, and use of fine motor skills. Occasionally sit, perform desk-based tasks, and lift up to 40 pounds. Rarely engage in strenuous physical activities.

Working Conditions:

Potential exposure to hazardous materials and chemicals, and risk of exposure to contagious diseases. May require extended or unusual hours based on research needs.

Working Standards:

Demonstrate commitment to safety, work well with colleagues and external organizations, and adhere to university policies and procedures.

Why Stanford?
Stanford University offers a supportive and enriching work environment with opportunities for career development, a caring culture, excellent health and wellness benefits, and access to a range of unique resources and activities.

Application Process:
To apply, submit your application and ensure all information is accurate. Stanford University is an equal opportunity employer and provides reasonable accommodations for applicants with disabilities. For more details, visit our Cardinal at Work website or contact Stanford University Human Resources.

Contact Information:
For accommodation requests, contact Stanford University Human Resources at stanfordelr@stanford.edu. For other inquiries, please submit a contact form.

Equal Opportunity Statement:
Stanford University is committed to providing equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Recommended Jobs

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

Live Support, Clinical Research Operations Specialist Ii (React)

Job Description

Recommended Jobs

Clin Data Assoc I

Clin Data Assoc Ii

Clin Data Assoc I

Ophthalmology - Cra Ii

Oncology - Cra Ii - Remote Us

Clin Data Assoc I

Clin Data Assoc Ii

Sr Clinical Data Associate

Sr Clinical Data Associate

Trial Delivery Specialist – Clinical Trial Coordination

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