About Us:
CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary:
The Clinical Research Quality Control (QC) Associate is responsible for ensuring the accuracy, consistency, and integrity of clinical trial documentation and processes. Working closely with clinical operations, data management, and regulatory teams, the QC Associate reviews essential trial documents and clinical data to verify compliance with GCP (Good Clinical Practice), ICH guidelines, regulatory requirements, and internal SOPs.
Essential Responsibilities and Duties:
- Performs quality control reviews of clinical trial documents (e.g., informed consent forms, case report forms, regulatory binders, monitoring visit reports) to ensure accuracy, completeness, and consistency.
- Identifies discrepancies, deviations, or data entry errors and follow up with appropriate teams for resolution.
- Supports the preparation and QC of Trial Master File (TMF) documents (paper and/or electronic).
- Assists in internal audits and inspection readiness activities.
- Collaborates with cross-functional teams (clinical operations, data management, regulatory affairs) to maintain high standards in documentation practices.
- Maintains and tracks QC metrics and contribute to quality improvement initiatives.
- Ensures that all clinical documentation complies with GCP, ICH, FDA, EMA, and company SOPs.
- Assists with SOP development and updates related to quality control activities.
- Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
- Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:
- Must be able to effectively communicate verbally and in writing.
- Bachelor’s degree in life sciences, healthcare, or a related field required. Advanced degree preferred.
- 1–3 years of experience in clinical research, with at least 1 year in a QC, QA, or documentation review role.
- Familiarity with clinical trial processes and regulatory requirements (GCP, ICH, FDA, EMA).
- Experience with electronic systems such as eTMF, EDC, and CTMS preferred.
- Strong attention to detail and organizational skills.
- Excellent written and verbal communication.
- Ability to work independently and in a team-oriented environment.
- Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
- Certification in clinical research (e.g., ACRP, SOCRA) is a plus.
- Experience in Phase I–IV trials or in a CRO environment.
Working Conditions
- Indoor, Office environment.
- Indoor, Clinic environment.
- Essential physical requirements include sitting, typing, standing, and walking.
- Lightly active position, occasional lifting of up to 20 pounds.
- Reporting to work, as scheduled, is essential.
- Occasional travel may be required (e.g., for audits or training).
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.