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Unblinded Study Jobs (NOW HIRING)

Clinical Research Coordinator

East Brunswick, NJ ยท On-site

$24.25 - $32/hr

If applicable, able to prepare blinded and unblinded study drugs. * If applicable, act as primary coordinators for unblinded team. Qualifications: * A Bachelor's degree or equivalent working ...

If applicable, able to prepare blinded and unblinded study drugs. * If applicable, act as primary coordinators for unblinded team. Qualifications: * A Bachelor's degreeor equivalent working ...

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Unblinded Study information

What is an unblinded study?

An unblinded study is a type of clinical research in which both the researchers and participants know which treatment or intervention is being administered. This contrasts with blinded studies, where one or both parties are unaware of the treatment allocation to reduce bias. Unblinded studies are often used when blinding is not feasible, such as in surgical interventions or certain behavioral studies. While they are easier to conduct, unblinded studies can be more susceptible to bias, so results must be interpreted carefully.

What is the difference between Unblinded Study vs Data Analyst?

AspectUnblinded StudyData Analyst
CredentialsTypically requires clinical research training, certifications in Good Clinical Practice (GCP)Requires degrees in statistics, mathematics, or related fields; certifications like CAP or Microsoft Excel certifications are common
Work EnvironmentClinical research settings, hospitals, or research organizationsOffice environments, data centers, or remote work
Industry UsagePharmaceuticals, clinical research organizations, healthcareVarious industries including healthcare, finance, marketing

Unblinded Study professionals focus on clinical trial phases where treatment groups are revealed, requiring clinical knowledge. Data Analysts interpret data across industries, including healthcare, often working with large datasets. While both roles involve data handling, their environments, credentials, and industry applications differ significantly.

What are some common challenges faced by professionals working on unblinded studies, and how can they be addressed?

Professionals involved in unblinded studies often face challenges related to maintaining objectivity and minimizing bias, since both participants and researchers are aware of the treatment being administered. This can influence data collection and interpretation. To address these challenges, teams typically implement rigorous protocols, frequent training, and independent data monitoring. Additionally, clear documentation and adherence to Good Clinical Practice (GCP) help ensure data integrity and regulatory compliance throughout the study.

What are the key skills and qualifications needed to thrive as an Unblinded Study Coordinator, and why are they important?

To thrive as an Unblinded Study Coordinator, you need a background in life sciences, clinical research experience, and knowledge of Good Clinical Practice (GCP) guidelines. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) tools, and relevant certifications like ACRP or SOCRA is typically required. Attention to detail, strong organizational skills, and effective communication are crucial soft skills for success in this role. These skills ensure protocol adherence, data integrity, and seamless collaboration with study teams in regulated clinical trial environments.
More about Unblinded Study jobs
What cities are hiring for Unblinded Study jobs? Cities with the most Unblinded Study job openings:
Infographic showing various Unblinded Study job openings in the United States as of June 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 1% Physical, and 99% Hybrid job distribution.
Unblinded Clinical Trial Manager

Unblinded Clinical Trial Manager

Scholar Rock

Cambridge, MA โ€ข On-site

Full-time

Posted 7 days ago


Job description

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Summary of Position:
Position Responsibilities
  • Facilitate internal project team meetings as needed
  • Serve as the primary unblinded point of contact for sites, vendors and CROs, pharmacists and any unblinded study staff
  • Review temperature excursions; collaborate cross functionally to ensure timely resolution of site inventory non-conformances
  • Assist with investigational product (IP) site forecasting as needed
  • Conduct unblinded review of multiple study documents and deliverables across functions
  • Review CRO Unblinded Monitoring Visit Reports (uMVRs)
  • Conduct unblinded co-monitoring visits in accordance with the Sponsor Oversight Plan as needed
  • Track key performance indicators (KPIs) to assess CRO CRA and site performance, ensuring compliance with ICH-GCP, SOPs, Local Regulations, Protocol and Monitoring Plans
  • Manage interactions with investigators and site personnel to ensure compliance with regulatory expectations
  • Proactively identify, mitigate and escalate risks or issues impacting study timelines
  • Ensure the unblinded portion of the Trial Master File (TMF), maintained at the CRO, remains inspection-ready; rountinely review for compliance and oversee remediation of findings as needed
  • Oversee the Site Pharmacy setup activities as needed and serve as a liaison between Sponsor and site pharmacy teams as needed
  • Participate in vendor, site and CRO audits as appropriate
  • Plan and present at Investigator Meetings as needed
  • Adhere to departmental SOPs, GCP/ICH guidelines and applicable QC/QA procedures
  • May require travel, including international travel
  • Collaborate with Clinical Supply to assist in managing Interactive Response Technology (IRT)
  • Participate in User Acceptance Testing (UAT) as applicable
  • Participate in product recall activities, if needed
  • Assist with collaboration between study sites and Sponsor to resolve product complaints

Candidate Requirements
  • BS/BA degree in a scientific discipline; advanced degree preferred
  • Minimum of 3 years demonstrated experience in a biotech/pharmaceutical/ CRO company, clinical research site or related healthcare company
  • Prior experience with a multi-phase clinical program or experience across multiple phases of clinical drug development
  • Highly organized, outcome oriented, self-motivated performance
  • Ability to adapt to change in a growth environment
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
  • Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
  • Understanding of the drug development process
  • Knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
  • Strong written and oral communication skills

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.