Clinical Study Specialist

Job Summary:

Clinical Study Specialist - Buckinghamshire-12 Month Contract
Requirements:

Title: Clinical Study Specialist

Location: Buckinghamshire

Develops, evaluates, and executes all essential clinical trial documents and clinical trial agreements (CTAs). Aligns execution activities with agreed upon project priorities, timings and quality specifications. Adheres to all relevant regulations including ICH and PhRMA guidelines and Client's SOPs and policies.
The employee must conduct their work activities in compliance with all Client internal requirements and with all applicable regulatory requirements. Client internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
The employee will have strong computer skills, good organizational skills, ability to prioritize and a good understanding of clinical study costs.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Client policies, and procedures. Client policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives

Key Interfaces

Routine contacts with Development Operations, Monitors, Global Project Team; Legal; Project Management; Medical Affairs; Biostatistics, Data Management and Programming; PSO; PK; Toxicology; Global Regulatory Compliance; Client's Therapeutic Areas; Regulatory Affairs; Corporate Communications. External interfaces include: vendors for clinical services, study sites, and therapeutic consultants.

KEY DUTIES AND RESPONSIBILITIES

Clinical Study Specialist

Responsible for the logistical tasks associated with the preparation, collation and review of the regulatory documents submission package. Ensures distribution of draft essential documents to the selected sites.
Responsible for drafting and reviewing of Study ICF. Responsible for the development of the Country-specific Informed Consent template by adapting the Study ICF templates with country-specific requirements.
Confirms the drug release documents are received in-house and follows-up with site if documents are missing or incomplete.
Responsible for on-going regulatory document maintenance. Responsible for the preparation, review, confirmation and distribution of the draft Clinical Trial Agreement and Budget to Site.
Responsible for the Negotiation with site on budget costs and contract language. Ensure follow-up with site if documents are missing or incomplete.
Ensure the preparation of the final Clinical Trial Agreement and budget and route for signature. Ensure the distribution of final documents as appropriate.
Responsible for managing amendments to the CTAs as necessary,

Registry Lead

Responsible for the review of the Clinical Study Registration Document against available study information to ensure its accuracy, completeness, and alignment with company and clinical study registry requirements.
Update the Clinical Study Registration Document as appropriate and work with the Clinical Study Team Lead to conduct a final review prior to posting.
Responsible for the posting the approved Clinical Study Registration Document to the appropriate clinical registry.

Clinical System Logistics Lead

Responsible for the set up, maintenance and metrics reporting from the CTMS system for clinical studies.
Provides support for CTMS users including reference data maintenance, system usage analysis, expertise in system functions and report requirements.
Participates in testing, validation and implementation of new CTMS features and other clinical system interfaces.
Provides centralized CTMS setup services including patient visit design and clinical cost tracking.

General Role

The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Client's policies, SOPs and Work Instructions.
Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks.
Other activities, special projects and assignments may be given as required.

Education and Experience

A Bachelor's degree, preferably in a science or health-related discipline
A basic understanding of contracts and negotiations is preferred.
Clinical research or Regulatory experience preferred.

Keywords:

Clinical Study Specialist, Clinical Studies, Clinical Trials, Study Start Up, CTA, CRA, ICF,
Clinical Study Specialist, Clinical Studies, Clinical Trials, Study Start Up, CTA, CRA, ICF,
Clinical Study Specialist, Clinical Studies, Clinical Trials, Study Start Up, CTA, CRA, ICF,
Clinical Study Specialist, Clinical Studies, Clinical Trials, Study Start Up, CTA, CRA, ICF,