Clinical Research Associate

Venesco,-LLC-; Frederick (MD); On-site; USD 75,000 - 120,000; Full time

Job summary

Venesco LLC is seeking a Clinical Research Associate (CRA) to provide clinical monitoring and oversight to ensure studies comply with protocols, GCP, FDA regulations, ICH guidelines, and sponsor requirements.

The CRA will conduct site qualification, initiation, monitoring, and closeout visits, perform SDV, review consent documentation, and oversee regulatory binders. Travel CONUS/OCONUS is required to support audits and inspections.

Qualifications

• Bachelor's degree required in life sciences, nursing, public health or related field.
• Minimum 3 years of clinical monitoring experience.
• Knowledge of FDA regulations, ICH-GCP and clinical research practices.

Responsibilities

• Conduct site qualification, initiation, monitoring, and closeout visits.
• Perform source data verification (SDV).
• Review informed consent documentation and study records.
• Evaluate protocol compliance and identify deviations.
• Review regulatory binders and essential documents.
• Generate monitoring reports and follow-up letters.
• Support site training and communication activities.
• Track CAPA implementation and assist with it.

Skills

Clinical monitoring

FDA regulations

IGC-GCP

Communication skills

Travel readiness

Education

Bachelor's degree in Life Sciences / Nursing / Public Health

Job description

Description

Clinical Research Associate

Venesco LLC is seeking a Clinical Research Associate (CRA) to provide clinical monitoring and oversight support to ensure studies are conducted in compliance with protocols, Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and sponsor requirements.

Duties and Responsibilities

• Conduct site qualification, initiation, monitoring, and closeout visits.


• Perform source data verification (SDV).


• Review informed consent documentation and study records.


• Evaluate protocol compliance and identify deviations.


• Review regulatory binders and essential documents.


• Generate clinical monitoring reports and follow-up letters.


• Support site training and communication activities.


• Track and assist with CAPA implementation.


• Support audit and inspection readiness.


• Maintain study documentation and monitoring files.

Minimum Qualifications

• Bachelor's degree in Life Sciences, Nursing, Public Health, or related discipline.


• Minimum 3 years of clinical monitoring experience.


• Knowledge of FDA regulations, ICH-GCP, and clinical research practices.


• Strong written and verbal communication skills.


• Ability to travel CONUS and OCONUS.

Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.

For more information on Venesco, LLC., visit https://venesco.com.