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.
Essential Functions:
Creates, maintains, and updates study details in CTMS and GoClinical. Including, but not limited to Sponsor, Study, Site and all related contact information, subjects, visits, issue tracking and all visit related details.
Serves as point of contact for day-to-day Site communications, document submissions and activity coordination.
Inventory management, oversight and coordination of shipping and tracking logistics in the field and within CTMS.
Assists GCPM with creation and development of study documents and training material as requested.
Completes site setup including DCV introduction and training.
Receives, tracks, reviews, manages, and distributes source documents from decentralized visits.
Attendance and minute keeping for all assigned KOMs, internal handoffs, vendor teleconferences and Sponsor teleconferences.
Establishes and maintains timely Sponsor, CRO, Site, and Central Lab communication as assigned by the GCPM.
Supports activities surrounding Decentralized Visits and GCC activities including but not limited to visit scheduling, courier booking, and sample collection and delivery coordination.
Tracking and metric reporting as directed by GCPM.
Assists with or completes audits of CTMS and GoClinical as directed by GCPM.
Assists GCPM with study closeout. Activities may include but are not limited to reconciliation of returned equipment from the field, reconciliation of CTMS and GoClinical.
Other duties as assigned.
Necessary Skills and Abilities:
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.
Professional, well spoken, articulate.
Advanced computer skills including experience with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat application are preferred.
Educational Requirements:
Bachelor’s degree or equivalent experience defined as a minimum of 3 years related, combined experience in education, knowledge and skills that will allow one to perform the tasks of the role proficiently.
Experience Requirements:
A minimum of 2 years clinical study or research, healthcare, or related experience.
#mk-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.***
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