Clinical Research Associate

About Us:

Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

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 Associate plays a vital role in the development of new medical treatments by monitoring clinical trials and ensuring they are conducted ethically, accurately, and in compliance with regulatory standards.

Essential Responsibilities and Duties:

• Monitors clinical trials to ensure adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements.
• Conducts site selection, initiation, monitoring, and close-out visits.
• Reviews case report forms (CRFs) for accuracy and completeness.
• Verifies source documents to ensure data integrity.
• Liaises between sponsors and clinical trial sites to resolve issues.
• Ensures timely reporting and resolution of adverse events.
• Maintains and updates study documentation and records.
• Trains site staff on study protocols and compliance procedures.
• Ensures proper handling and storage of investigational products.
• Prepares monitoring visit reports and presents findings.
• 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, health sciences, nursing, or a related field.
• 1–3 years of experience in clinical research.
• Certification from recognized organizations (e.g., SOCRA, ACRP) is a plus.
• Strong understanding of clinical trial processes, GCP, and regulatory guidelines.
• Excellent attention to detail and organizational skills.
• Proficiency with clinical trial management systems (CTMS) and Microsoft Office Suite.
• Strong communication and interpersonal skills.

Working Conditions

1. Indoor, Office environment.
2. Essential physical requirements include sitting, typing, standing, and walking.
3. Lightly active position, occasional lifting of up to 20 pounds.
4. Reporting to work, as scheduled, is essential.
5. Willingness to travel (up to 75%) for site visits.
6. In office or remote when not traveling. At clinical research sites while monitoring · Frequent travel to trial sites required.

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.