Job Title: Clinical Trial Associate
Location: Durham, North Carolina
Reports to: Director, Clinical Operations
Our Core Values:
All employees, including Executives, are expected to uphold REVOLO’s Core Values. These are the values we hold which form the foundation on which we interact and collaborate, perform our work, and conduct ourselves. They are the guiding practices we are expected to use every day in everything we do.
Revolutionary I Excellence I Respect I Integrity I Trust I Patient Well-being
Who We are:
If you’re looking for a typical biotechnology company, you’ve come to the wrong place.
We are a revolutionary biotherapeutics company and our mission is to revolutionize autoimmune and allergic disease treatment by resetting the immune system for superior long-term disease remission.
How We Succeed:
By developing therapies that achieve superior long-term disease remission from less frequent chronic dosing and without suppression of the immune system. A goal that others haven’t been able to reach.
Why We Do What We Do:
Existing therapies for autoimmune and allergic diseases require frequent chronic dosing, provide only short-term disease remission in a limited number of patients and suppress the immune system, ultimately putting patients at risk of developing serious infections and life-threatening side effects.
How You’ll Contribute:
The Clinical Trial Associate will work closely with clinical operations and help plan clinical trial execution with the expectation and vision to obtain the highest data quality in a manner compliant with quality standards, regulatory guidance and within budget. This is a hands-on role that will assist with documenting and reporting the clinical development program, study sites, clinical trial vendors as well as the execution, and completion of clinical trials. The position will work cross-functionally to ensure quality clinical operations execution.
- Support clinical study documentation preparation, tracking and maintenance.
- Maintain trial master files (TMFs) and study documentation in accordance with regulatory requirements and internal SOPs.
- Develop and maintain study-related trackers to support Clinical Operations
- Assist in planning, organizing. and executing study-specific meetings. Write and distribute agendas. minutes. and regular updates..
- Maintain and update the study team list. including vendor contact information.
- Review and update system access user lists at pre-specified frequencies.
- Participate in reviewing, formatting, and finalizing study-related templates, logs, plans, and manuals.
- Support the monitoring and tracking of a study progress, including- patient recruitment and enrollment, to ensure adherence to study timelines and milestones.
- May ;support financial tasks for the study (e.g. investigator/institution/vendors payments), coordinating tracking.
- Perform other duties in support of Clinical Operations, as required.
- Other duties as assigned.
Position Requirements And Experience:
- Bachelor’s or advanced degree in a relevant scientific discipline (e.g., Life Sciences, Pharmacy, Nursing or Medicine).
- Previous experience working as a Clinical Trials Associate Study Coordinator or in a similar role within the pharmaceutical, biotechnology, or CRO industry preferred.
- 2 or more years working within pharmaceutical, biotechnology, or CRO industry is preferred.
- Knowledge of clinical trial regulations, guidelines, and best practices, including ICH¬GCP and FDA requirements.
- Strong organizational skills and attention to detail, with the ability to manage multiple tasks and prioritize workload effectively.
- Excellent written and verbal communication skills with the ability to effectively interact with study team members and internal and external stakeholders.
- Ability to work independently as well as collaboratively in a team-oriented environment.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project).
This position requires extended periods of sitting and working on a computer. Must have the ability to navigate travel both internationally and domestic.
Revolo Biotherapeutics is an Equal Opportunity/Affirmative Action Employer – EOE Minorities/ Females / Protected Veterans / Individuals with Disabilities.