Biomarker Consent Specialist

Parexel•Southport, NC

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Join Parexel’s team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of everything we do. Job Title: Biomarker Consent Specialist At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life- changing medicines to patients. We are seeking a Biomarker Consent Specialist to join our team. As a Biomarker Consent Specialist, you’ll be joining a fast-paced, driven environment that’s helping to make life-changing differences to patients by negotiating, authoring, and reviewing genetic and biomarker language in clinical trial informed consents. Through the collaboration and diversity of teams, the Biomarker Consent Specialist is provided with multiple opportunities to excel and discover where your skills can take you.

Requirements

Exceptional communicator to partner effectively with internal and external teams
Self‑motivated professional who can work independently and collaboratively
Critical thinker able utilize and discern guidance documents as they apply to clinical trial informed consents
Proactive problem solver to identify issues, propose solutions, and drive resolution
Detail oriented individual with the ability to manage multiple assignments under accelerated timelines
Quick learner who can become proficient in client tools, databases, and systems
Proficient MS Office Suite user
Bachelor’s degree (BA/BS) required
Minimum of 5 years of experience working with global clinical trials and associated systems (eTMF, LIMS, or similar) AND proven experience with genetic informed consents and global consent negotiation

Responsibilities

Author, review, and negotiate genetic and biomarker language within clinical trial informed consent documents
Document restrictions related to genetic and biomarker research on clinical trial samples
Understand and apply company policies and procedures to ensure consistency and compliance in informed consent language
Collaborate with global stakeholders to negotiate informed consents across multiple regions
Utilize clinical trial systems (eTMF, LIMS, etc.) to support documentation and workflow needs
Manage multiple concurrent assignments while meeting accelerated project timelines
Provide clear communication and partnership to cross‑functional teams to achieve study and organizational goals