Site Readiness And Regulatory Specialist 2

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:

Adherence to SOPs: Ensure strict compliance with standard operating procedures (SOPs).
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.
Issue Escalation: Identify and escalate issues to line management as per departmental processes.
Quality Control: Oversee the quality of tasks completed by Contracts Associates.
Study Management: Ensure assigned studies comply with internal processes and Sponsor requirements.
Contract Tracking: Timely update the departmental contract and amendments tracking system.
Contract Administration: Assist with contract approvals, maintain a tracking system, provide status updates, and manage the scanning and filing of executed contracts.
Support Department Goals: Assist line management with departmental goals and initiatives positively and flexibly.
Status Reporting: Regularly update management on the status of open contracts and any outstanding issues.
Corporate Compliance: Adhere to corporate requirements, including timesheet entries, training documentation, and expense report submissions.
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.
Professional Negotiation: Negotiate terms with contracting parties in a professional manner.
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.
Communication: Collaborate with staff to keep them informed of agreement progress and avoid execution delays.
Support and Assistance: Provide support to Site Agreements staff and assist with contractual inquiries.
Internal Review: Facilitate the internal review, revision, and sign-off process for contracts before forwarding them to external parties.
Coordination: Communicate with clinical study teams regarding contract details, timelines, and status reporting to ensure timely approval.
Compliance: Apply knowledge of ICH GCP principles and follow quality standard procedures.
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.

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Site Readiness And Regulatory Specialist 2

Job Description

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