• Login / Signup
    • Instagram
    youtube
    Facebook

    Site Readiness And Regulatory Specialist 2

    Fortrea
    1-3 years
    Not Disclosed
    Bangalore
    10 Sept. 5, 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

    About Fortrea

    Fortrea, a leading global Contract Research Organization (CRO), is dedicated to scientific excellence and clinical development. With decades of experience, we deliver comprehensive clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Our global team of over 19,000 professionals operates in more than 90 countries, advancing drug and device development to benefit partners and patients worldwide.

    Position: Contracts and Site Agreements Specialist

    Responsibilities:

    1. Adherence to SOPs: Ensure strict compliance with standard operating procedures (SOPs).
    2. Site Agreements Management: With occasional guidance, manage daily tracking, negotiation, and approval of Site Agreements and amendments, including Clinical Study Document Amendments (e.g., ICF, Protocol) and Site Agreement templates. Update the Site Agreement Management System (SAMS) or other relevant systems as required.
    3. Issue Escalation: Identify and escalate issues to line management as per departmental processes.
    4. Quality Control: Oversee the quality of tasks completed by Contracts Associates.
    5. Study Management: Ensure assigned studies comply with internal processes and Sponsor requirements.
    6. Contract Tracking: Timely update the departmental contract and amendments tracking system.
    7. Contract Administration: Assist with contract approvals, maintain a tracking system, provide status updates, and manage the scanning and filing of executed contracts.
    8. Support Department Goals: Assist line management with departmental goals and initiatives positively and flexibly.
    9. Status Reporting: Regularly update management on the status of open contracts and any outstanding issues.
    10. Corporate Compliance: Adhere to corporate requirements, including timesheet entries, training documentation, and expense report submissions.
    11. Contract Drafting and Negotiation: Draft, negotiate, and process contracts and amendments to protect Fortrea's interests. Ensure contracts and amendments accurately reflect obligations and rights.
    12. Professional Negotiation: Negotiate terms with contracting parties in a professional manner.
    13. Obstacle Resolution: Identify potential obstacles in the contracting process and seek assistance from line management, project management, Business Development, or Budgets & Proposals staff to minimize delays.
    14. Communication: Collaborate with staff to keep them informed of agreement progress and avoid execution delays.
    15. Support and Assistance: Provide support to Site Agreements staff and assist with contractual inquiries.
    16. Internal Review: Facilitate the internal review, revision, and sign-off process for contracts before forwarding them to external parties.
    17. Coordination: Communicate with clinical study teams regarding contract details, timelines, and status reporting to ensure timely approval.
    18. Compliance: Apply knowledge of ICH GCP principles and follow quality standard procedures.
    19. Additional Duties: Perform other related duties as required by the department.

    Qualifications:

    • Education: Bachelor's degree in a relevant field.
    • Experience: Minimum of 1-3 years of experience in contract management or site agreements within clinical trials.
    • Knowledge: Understanding of GCP, ICH Guidelines, and local regulations.
    • Skills: Excellent administrative, organizational, and communication skills. Ability to manage multiple priorities and meet deadlines.
    • Technical Proficiency: Competence in using contract tracking systems and general computer literacy.

    Work Environment:

    • Full-time position with occasional flexibility in working hours as needed.

    Join Us:

    Fortrea is seeking proactive problem-solvers and innovative thinkers passionate about advancing clinical trials. Join our dynamic team to contribute to meaningful global impact and personal growth in a collaborative environment. For more details, visit www.fortrea.com.

    Equal Opportunity Employer:

    Fortrea is committed to diversity and inclusion. We do not tolerate harassment or discrimination and base employment decisions on qualifications and business needs. All qualified candidates are encouraged to apply.

    For details on how we handle your personal data, please refer to our Privacy Statement.

    Latest Jobs

    Quality Specialist Ii - 100% Remote - Pharmacovigilance Compliance

    On-Board Companies
    Remote

    Medical Affairs Manager

    Us Tech Solutions
    Titusville

    Sr. Scientist - In Vivo Pharmacology (Inflammation Research)

    Amgen
    Remote, USA

    Associate Medical Safety Director

    Iqvia
    Belgrade

    Sponsor Dedicated Cra Ii

    Syneos Health
    Remote - Europe

    Cra Ii

    Syneos Health
    Remote, USA

    Clinical Research Scientist Ii

    Teva Pharmaceuticals
    Mumbai

    Sr. Pv Professional

    Teva Pharmaceuticals
    Bangalore

    Pv Professional

    Teva Pharmaceuticals
    Bangalore

    Scientist - Molecular Biology & Pharmacology

    Amgen
    San Francisco

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    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 |

    Pharma Jobs in United States

    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 :

    Denver |

    Connecticut :

    Storrs |

    D.C :

    Washington |

    Florida :

    Coral Gables | Gainesville | Jacksonville | Orlando | Rueil-Malmaison | Tallahassee | West Palm Beach |

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    Maryland :

    Baltimore | Rockville |

    Massachusetts :

    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 :

    Ambler | Philadelphia | Pittsburgh |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Denmark :

    Copenhagen |

    Hungary :

    Budapest |

    Serbia :

    Belgrade |

    Switzerland :

    Basel |

    Pharma Jobs in Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Republic of China :

    Beijing |

    Tokiyo :

    Tokyo | Osaka |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    London | Salt Lake City |

    Republic of Ireland :

    Dublin | Limerick |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Remote :

    Remote, USA | Switzerland | Remote - Europe | Remote |

    Makkah :

    Rabigh | Khulais | Najran | Riyadh | Jeddah |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |