Job description

JOB DESCRIPTION

• Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents

• Directly communicate with sites to facilitate start-up and continue active collaboration with sites throughout maintenance and close-out.

• Recognize, discuss, and resolve problems.

• Ensure that submission paperwork and any additional documents/systems meet country-specific regulatory and data privacy laws.

• Effectively drive new work by leveraging existing site / review board engagements.

• Fill internal systems to verify trial / site performance correctness.

• Directly communicate with sites to facilitate start-up and continue active collaboration with sites throughout maintenance and close-out.

• Recognize, discuss, and resolve problems.

• Ensure that submission paperwork and any additional documents/systems meet country-specific regulatory and data privacy laws.

• Effectively drive new work by leveraging existing site / review board engagements.

• Understand and follow procurement, legal, and financial policies and procedures.

• Create Trial Master Files and libraries for future use.

• Provide comments and shared learning in order to develop continuously.

• Make use of trial prioritisation

• Anticipate and monitor shifting priorities.

ESSENTIAL SKILLS / QUALIFICATIONS:

• A bachelor's degree, ideally in a scientific or health-related subject, is required, as is two years of clinical research experience or similar expertise.

• Knowledge of the entire clinical development paradigm and the significance of timely site initiation

• Demonstrated understanding of project management methods and abilities

• Understanding of and experience in a compliance-driven workplace

• The ability to learn and follow financial and legal regulations and norms (budget and contract)

• Strong communication, negotiating, and problem-solving abilities

• Organizational and self-management abilities

EXTRA SKILLS/PREFERENCES:

Language skills in the followings – Spanish & English

Job Types: Full-time, Permanent

Benefits:

• Bike to work scheme
• Company pension
• Gym membership
• On-site parking
• Private medical insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Yearly bonus

Ability to commute/relocate:

• Cork, County Cork: reliably commute or plan to relocate before starting work (preferred)

Reference ID: SM

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