Study Coordinator - High Point, NC

propharmagroup; United States; Hybrid; USD 55.000 - 75.000; Vollzeit

Zusammenfassung

ProPharma Group seeks a Central Study Coordinator to support remote site activities; you will coordinate communications, data handling, and regulatory documentation. The role requires collaboration with the Principal Investigator and site staff across multiple projects.

You will manage pre-screening and recruitment tasks, assist with consent and records, and ensure IRB/FDA policy adherence while maintaining data integrity in clinical databases.

Qualifikationen

• Bachelor's degree or equivalent with related experience.
• Knowledge of ICH/GCP and regulatory guidelines is preferred.
• Experience in clinical studies or site coordination is ideal.

Aufgaben

• 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.
• Handle subject re-consenting, medical records, protocol activities per PI direction.
• Perform data-entry and monitor clinical databases; respond to system queries.
• Establish and maintain timely site communications as needed.
• Maintain documentation compliant with IRB/FDA policies.
• Assist with study closeout and other study-related activities.
• Other duties as assigned.

Kenntnisse

Independent work

Strong communication

Critical thinking

Regulatory knowledge

Team collaboration

Privacy & compliance

Ausbildung

Bachelor's degree or equivalent experience

Jobbeschreibung

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. 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.

• The Central Study Coordinator position is responsible for the coordination and support of remote site activities for assigned projects and must reside in or near High Point, NC.

Essential Functions:

• Serve as point of contact for day-to-day Site communications, document submissions andactivity 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.
• EstablishandmaintaintimelySitecommunicationasassigned.
• Maintain documentation which complies with IRB/FDA policies.
• Assistwithstudy closeout.
• Assistsitewithotherstudy-relatedactivitiesasdirected.
• Otherdutiesasassigned.

Necessary Skills and Abilities:

• Ability to manage technology and web-based research platforms on PC (Microsoft OS) laptop in the remote workspace.
• Study Tearn 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.

Educational Requirements:

• Bachelor'sdegreeorequivalentexperiencedefinedasaminimumof 2 years related,combined experience in education, knowledge and skillsthatwillallowonetoperformthetasksoftheroleproficiently.

#LI Remote

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.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***