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Vacancy Details
Job Reference: INC 2
Job Title: Home or office Based Senior Clinical Research Associate (UK)
*
Location: Home or office Based UK
Salary: Attracive salary
Job Type : Full Time - Permanent
Sector/Job Title:  Clinical Research
Salary:  All
Role Levels: 
Company : INC Research
Job Description : INC Research is a specialised Clinical Research Organisation with a long-standing history of therapeutic specialty and technological innovation.

POSITION SUMMARY:

Responsible for monitoring all types of clinical trials; assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.

ESSENTIAL JOB FUNCTIONS:

1. Communication
• Maintains timely and effective communication among team members.
• Keeps project leadership apprised of team issues, seeking guidance as needed.
• Participates in Business Development client presentations and bid defenses as requested.

2. Regulatory Documentation
• Assures compliance with CFR, State regulations, ICH and GCP guidelines and INC Research and sponsor SOPs.
• Maintains current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.
• Participates in TMF and on-site audits as requested.

3. Monitoring
• Assumes responsibility for site management and site staff performance including,
• Monitors all types of clinical trials.
• Participates in all types of site visits.
• Assures Principal Investigator (PI) integrity.
• Assures compliance with all protocol requirements.
• Assures effective patient identification and recruitment plan is in place.
• Assures timely reporting of AEs/ SAEs and Protocol Violations.
• Regularly perform Investigational Product (IP) accountability.
• Regularly review the status of contents of the site Regulatory Binder.
• Participates with assessment of less experienced CRAs for the sign off visits after approval by manager and completion of required training.

4. Data Handling
• Performs source document verification (SDV) according to contractual requirements.
• Assures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP).
• Assures timely and accurate completion of Data Clarification Forms (DCFs).
• Performs clinical data listings reviews as needed.

5. Reporting and Tracking
• Completes and submits visit trip reports according to SOP requirements and requiring minimal revisions.
• Maintains awareness of key study performance indicators for own sites, e.g. patient enrollment, SAEs.
• Updates study and patient status information and serves as (CTMS) resource for PM/LCRA.
• Tracks Investigator payments/ milestones, if requested.
• Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.

6. Administrative
• Assists with preparation and attends investigator’s meetings as requested. May present as requested.
• Assists with the preparation of study start up materials and tools, as requested.
• Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project Communication, Monitoring and / or Training Plans.
• May assume Clinical Team Lead/ Lead CRA role and/ or assist with LCRA activities, e.g., tool development, study plans, team training.


EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:

Requires a BA/BS degree in the science/health care field, nursing degree, or equivalent combined education and experience plus moderate clinical or related research experience with some of independent field monitoring experience or equivalent. ACRP certification preferred and required within one year of being placed in role. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail are required.
To apply for any of the position or for more information please e-mail your CV to: europejobs@INCResearch.com


 
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