Study Coordinator - High Point, NC

PPG US ProPharma Group, LLC; Raleigh (NC); Hybrid; USD 52,000 - 76,000; Full time

Job summary

ProPharma is seeking a Central Study Coordinator to support remote site activities for assigned projects. The role requires coordinating day-to-day site communications, data entry, and regulatory documentation in accordance with IRB/FDA policies.

The candidate will assist with pre-screening, screening and recruitment, and may participate in study closeout while collaborating with Principal Investigators and cross-functional teams.

Qualifications

• Bachelor's degree or equivalent experience with at least 2 years related experience.
• Ability to work independently and in a team.
• Strong written and verbal communication.
• Knowledge of ICH/GCP regulations.
• Familiarity with SOPs and global regulations.

Responsibilities

• Serve as point of contact for day-to-day site communications and document submissions.
• Support pre-screening, screening and recruitment activities.
• Conduct subject re-consenting and obtain medical records.
• Perform data-entry and monitor clinical databases.
• Maintain timely site communications.
• Ensure documentation complies with IRB/FDA policies.
• Assist with study closeout and other study-related activities.

Skills

Remote work setup

Study Team experience

Critical thinking

Communication skills

Independent worker

Privacy conscious

ICH/GCP knowledge

SOPs compliance

Education

Bachelor's degree or equivalent

Job description

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 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.
• Other duties as assigned.

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'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.

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 will never ask you for any bank account information, financial information, or another form of payment to be considered for a role. Additionally, the ProPharma talent acquisition team will only use their work email addresses ([e-mail]). If you receive recruiting communications from anyone with a yahoo.com, gmail.com, live.com, propharmagroupjobs.com, or any other email account, it’s likely a fraud.