On-Site Study Coordinator

ProPharma • Raleigh, NC

3d • Hybrid

About The Position

The On-Site Study Coordinator/Research Assistant position is responsible for the coordination and support of remote site activities for assigned projects. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Requirements

• Ability to manage technology and web-based research platforms on PC (Microsoft OS) laptop in the remote workspace; Study Team experience is ideal
• Critical thinking skills
• Strong communication Skills (verbal and written)
• Ability to work independently, and collaboratively with other CSCs to delegate tasks as needed
• Working location that has the ability to maintain privacy
• Current knowledge of and the ability to apply ICH / GCP and applicable regulations and guidelines.
• Competent in the application of standard business procedures including but not limited to SOPs, global regulations.
• Well organized and able to multitask.
• Able to work independently and as a team member.
• Able to take initiative while following directives.
• Bachelor’s degree or equivalent experience defined as a minimum of 2 years related, combined experience in education, knowledge and skills that will allow one to perform the tasks of the role proficiently.
• Minimum 2 years of study coordinator experience .
• Bachelor’s degree or equivalent experience defined as a minimum of 1 year related, combined experience in education, knowledge and skills that will allow one to perform the tasks of the role proficiently.

Nice To Haves

• Research Assistant Position Requirements
• Research experience preferred.

Responsibilities

• Serve as point of contact for day-to-day Site communications, document submissions and activity coordination.
• Support pre-screening, screening and recruitment activities, as assigned.
• Responsible for subject re-consenting, acquiring medical records, conducting protocol activities, as directed by the Principal Investigator.
• Perform data-entry, evaluate and respond to system queries and monitor clinical databases as assigned.
• Establish and maintain timely Site communication as assigned.
• Maintain documentation which complies with IRB/FDA policies.
• Assist with study closeout.
• Assist site with other study-related activities as directed.

Benefits

• We celebrate our differences and strive to create a workplace where each person can be their authentic self.
• We are committed to diversity, equity, and inclusion.
• Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
• With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
• All applications to roles at ProPharma are personally reviewed by a member of our recruitment team.
• We do not rely on AI screening tools to support our hiring process.
• You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree