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Clinical Trial Associate

2 months ago


Emelle Alabama, United States Pharmaceutical Research Associates, Inc Full time

Overview:


As a Clinical Trial Associate, you will become part of a leading and extensive clinical research organization, driven by healthcare insights.


Responsibilities:

Your Role:
Embody and uphold the core values of our organization, which focus on excellence in execution, surpassing expectations, and fostering strong relationships.

As a team member, you are expected to engage in and contribute to our culture of continuous improvement, emphasizing the optimization of our processes to add value to our operations and fulfill client requirements.

Travel may be required (approximately 10%) for domestic and/or international assignments.

Possess a solid understanding of ICH GCP, relevant regulations, applicable standard operating procedures (SOPs), internal tracking systems, and client-specific protocols when necessary.

Assist project teams in the establishment, organization, and upkeep of clinical study documentation (e.g., Study Files, Case Report Forms) and guidelines, including preparation for audits, final reconciliation, and archival.

Support the processing of Data Collection Forms, including logging, tracking, and quality control as appropriate for the study.

Share responsibility for quality control audits of clinical study documentation to ensure that study files are always ready for inspection.

Facilitate and coordinate the ordering, dispatch, and tracking of trial materials (e.g., Case Report Forms, diary cards, lab supplies, and study binders) as necessary.

Assist project teams in tracking trial progress by updating Clinical Trial Management Systems and providing access to study/client systems as appropriate.

Generate, review, and analyze study reports for accuracy, collaborating with project teams to ensure timely updates.

Assist in coordinating study-related payments, if applicable.

Act as a point of contact for clinical sites for basic inquiries (e.g., enrollment updates, missing documentation, meeting arrangements).

Help track and distribute safety reports.

Coordinate document translation when required.

Support project teams by coordinating meetings, preparing activities, and generating meeting minutes and agendas.

Assist in creating presentation materials, such as slides and overheads, for project, departmental, sponsor, and business development purposes.

Help coordinate various tracking reports, including team member tracking and training.

Collaborate with internal and external colleagues to achieve project objectives and timelines.

Keep the Project Manager/Project Director informed of any issues within the Project Team that require attention.

Maintain confidentiality of client and patient information.

Qualifications:

Requirements:
High School Diploma or Equivalent

Bachelor's Degree or Equivalent
Fluent in English

What We Offer:
Our success relies on the quality of our workforce. Therefore, we prioritize building a diverse culture that recognizes high performance and nurtures talent.

In addition to a competitive salary, we provide a variety of benefits designed to support well-being and work-life balance for you and your family.

Examples of our benefits include:


Various annual leave entitlements

A range of health insurance options tailored to your family's needs

Competitive retirement planning options to maximize savings and ensure future security

Global Employee Assistance Program, offering 24-hour access to a vast network of specialized professionals for your family's well-being

Life insurance

Flexible, country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, and health assessments.

Visit our careers website to learn more about the benefits of working with us.

Commitment to Diversity:
We believe that diversity, inclusion, and belonging are fundamental to our culture and values. Our diverse workforce enhances our innovation and enables us to better serve our people, patients, customers, and communities. We are dedicated to providing an inclusive and accessible environment for all candidates. We are committed to a workplace free of discrimination and harassment.

All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require reasonable accommodation due to a medical condition or disability during the application process or to perform essential job functions, please inform us through the appropriate channels.


We encourage you to apply even if you are unsure about meeting all the requirements – you may be the perfect fit for this or other roles.