Initiation Clinical Research Associate I / Study Start Up

The main responsibility of the Initiation Clinical Research Associate (iCRA) is to conduct and facilitate specific start-up activities such as feasibility, site identification, pre- qualification, Site Regulatory Package (SRP) review and approval, Informed Consent (ICF) customization, IRB/IEC application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures.

Key Accountabilities:

• Conduct country specific feasibility and/or site pre-qualification.

• Review and validate site identification list.

• Collect and negotiate Confidentially Agreements (CDA) as required.

• Organize translations per country/regulatory/client requirements.

• Review and approve country specific and/or site specific documents or essential regulatory documents (SRP).

• Customize, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments.

• Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and amendments).

• Prepare and negotiate as required initial and/or amended CSA at a site level.

• Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader (SCL) as required.

• Collect internal CSA signatures.

• Complete routine departmental administrative tasks in an accurate and timely manner (e.g. timesheets, metrics, etc.).

• Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacity).

• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL training requirements, and study specific procedures and training.

• Ensure basic understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery.

• Update all appropriate Clinical Trial Management Systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files per the Central File Maintenance Plan.

• Escalate any site and study issues that require immediate action to the Functional Lead (FL).

• Proactively work with other project team members to meet project goals.

• Show commitment and perform consistent high quality workQualificationsSkills:

• Client focused approach to work.

• Ability to interact professionally with external customers.

• Ability to manage multiple and varied tasks with enthusiasm.

• Attention to detail.

• Willingness to work in a matrix and virtual team environment and to value the importance of teamwork.

• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic .Document Management System (EDMS), and MS- Office products such as Excel and Word.

• Sound interpersonal, verbal, and written communication skills.

• Sound problem solving skills.

• Sense of urgency in completing assigned tasks.

• Effective time management in order to meet daily metrics, team objectives, and department goals.

• Developing ability to work across cultures.

• Ability to influence and negotiate resolutions and outcomes with sites and IRBs/IECs.

• Willing and able to travel locally and internationally occasionally as required.

Education:

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred).

Language Skills:

• Proficient in written and oral English and Spanish languages.

Minimum Work Experience:

• Previous documented relevant work experience in clinical research (Site Management experience, Start Up experience).

If you are ready to join PAREXEL’s Journey, please apply!