Contract
Senior Clinical Research Associate
Premier Research International
1,001-5,000 employees
Contract research organization for clinical development
No salary listed
Remote in USA
Remote
Remote within the United States; willing to travel up to 70-85%.
 Biology & Biotech (1) |
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- Experience in Neurology or Psychiatry, including work with Schedule I controlled substances, is required.
- Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience.
- 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Alternately, must have proven experience in all primary job functions.
- Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities.
- Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials.
- Willingness to travel up to 70-85%
- Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records.
- Issues, investigates, and resolves any data discrepancies identified during source verification activities.
- Maintains thorough documentation and proper escalation of issues related to visit reports.
- Ensures any identified non-compliance issues are addressed.
- Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
- Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database.
- Performs budget negotiations with clinical trial sites.
Premier Research provides specialized clinical development services for biotech and specialty pharma, focusing on specific therapeutic areas where science is advancing. It supports end-to-end clinical trials, including study design, site management, data handling, statistics, regulatory affairs, and medical writing, across more than 20 countries with about 1,500 employees. Customers partner with Premier Research to plan and run development programs with cross-functional teams that design trials, manage sites and data, analyze results, and prepare regulatory submissions. The company aims to help biotech and pharma bring safe, effective therapies to patients faster by delivering high-quality clinical development and regulatory support.
Company Size
1,001-5,000
Company Stage
Acquired
Total Funding
$79.2M
Headquarters
Morrisville, North Carolina
Founded
1989
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Simplify's Take
What believers are saying
- Paul Spreen brings IQVIA-scale commercial discipline to global growth.
- Milena Kanova-Petrova deepens general medicine execution in internal medicine and dermatology.
- BioCentriq partnership strengthens cell therapy development and pre-IND acceleration.
What critics are saying
- IQVIA and larger CROs pressure enterprise biotech deals with broader bundled services.
- Biotech funding freezes cut sponsor budgets, delaying trials and reducing utilization.
- Crowded general medicine and digital trial markets compress margins and raise switching risk.
What makes Premier Research International unique
- Focused CRO expertise in oncology, rare disease, neuroscience, and women’s health.
- End-to-end support spans preclinical planning through commercialization.
- Operates globally across more than 20 countries with specialized clinical teams.
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Benefits
Flexible Work Hours
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 1%2 year growth
↑ 17%Premier Research, a global clinical research and product development company, has appointed Paul Spreen as Chief Commercial Officer. Spreen brings over 25 years of life sciences leadership experience and will oversee global commercial strategy, business development, marketing and proposals. Spreen previously served as EVP and Chief Commercial Officer at IQVIA (formerly Quintiles), where he held several global leadership positions. His experience spans the full drug development lifecycle, from early discovery through commercialisation, with a focus on scaling organisations during periods of rapid growth and M&A. In his new role, Spreen will drive sustainable growth, strengthen customer engagement and advance Premier's position across the drug development spectrum. The Morrisville, North Carolina-based company specialises in clinical trials and regulatory strategy for the biotechnology sector.
MORRISVILLE, NC, April 1, 2024 – Premier Research is pleased to announce the addition of Dr. Milena Kanova-Petrova as Senior Vice President, Global Head of General Medicine. In this role, Dr. Kanova-Petrova will oversee strategic planning and project execution for all general medicine clinical operations inclusive of internal medicine, women’s health and dermatology.“Our customers are breaking barriers and forging new pathways every day in the pursuit of bettering patient care. The work is complex and specialized, and adding Dr. Kanova-Petrova to our Clinical Leadership Team expands the specialization that we can provide to our customers,” said Premier Research Chief Operating Officer, Michael Arlotto, Ph.D
Recruitment is essential for generating data on drug efficacy, which is crucial for the approval of new medical treatments. Clinical trial success hinges on the ability to recruit a sufficient and appropriate number of participants. As Cara Brant, chief executive officer (CEO) of Clinical Trial Media puts it, “Trials are intended to generate data on how a drug works and you can’t generate that data if you don’t have participants in the study. This makes recruitment one of the linchpins of clinical research and drug development as a whole.”However, the landscape of clinical trial recruitment is becoming increasingly competitive. With over 450,000 clinical trials in progress globally, according to Brant. The task of recruiting participants has never been more challenging
TrialHub, a leading platform for patient feasibility in clinical trials, is proud to announce its collaboration with Premier Research.
MORRISVILLE, N.C. and NEWARK, N.J., Jan. 8, 2024 /PRNewswire/ -- Premier Research, a preeminent global clinical research, product development, and consulting company, and BioCentriq, a renowned Contract Development and Manufacturing Organization (CDMO), have entered a strategic partnership to revolutionize the pre-Investigational New Drug (IND) process and accelerate the clinical translation of novel cell therapy products.Premier Research/BioCentriq LogoBy leveraging Premier Research's expertise in cell therapy product development and BioCentriq's proficiency in developing and manufacturing and testing cell therapies, the partnership will streamline the process of bringing new products to patients. As partners, Premier and BioCentriq are well positioned to support sponsors seeking to expedite the transition of their innovative cell therapy candidates from research to clinical trials."Partnering with BioCentriq aligns with our commitment to expediting the development of transformative cell therapies," stated Kenneth Ndugga-Kabuye, MD, FACMG, Vice President, Cell and Gene Therapy at Premier Research. "By merging our comprehensive product development expertise with BioCentriq's specialized capabilities we will help sponsors simplify the development process from pre-IND through approval, ultimately accelerating the delivery of innovative therapies to patients in need."This collaboration will harness Premier Research's comprehensive understanding of regulatory requirements, clinical trial design and study execution, alongside BioCentriq's specialized capabilities in cell therapy development."Cell therapy development is extremely complex," added Olu Aloba, PhD, Vice President, Chemical Manufacturing and Control (CMC) Services, Premier Consulting, a business unit of Premier Research, "Nonclinical and Clinical development, CMC, and the CDMO have to work hand in hand to address the scientific, logistical and regulatory demands that enable studies to generate high-quality results.""This collaboration marks a significant step in fostering a more streamlined pathway for groundbreaking cell therapies," remarked Alex Klarer, Vice President, Business Strategy and Innovation at BioCentriq. "Combining Premier Research's clinical insights with our CDMO expertise will empower us to expedite the translation of novel therapies from the lab to clinical reality, benefiting patients worldwide."About Premier ResearchPremier Research, a global clinical research, product development, and consulting company, is dedicated to helping biotech, specialty pharma, and medtech innovators transform life-changing ideas and breakthrough science into new medical treatments.Premier Research specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.Whether it's developing product lifecycle strategies, reducing clinical development cycle timelines, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier Research is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions