Clinical Research Associate II

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Perform site qualification, initiation, interim monitoring, and close-out visits.

• Supervise the execution of studies, source documentation, informed consent, subject safety information, and case report forms (CRFs).

• Evaluate and train site personnel on protocol stipulations.

• Address compliance and study-related challenges.

• Ensure that regulatory, ethics, and site documentation is complete, up-to-date, and maintained for the Investigator Site File and Trial Master File.

• Resolve data inquiries with sites and ensure timely data submissions.

• Ensure appropriate reporting and follow-up on safety events.

• Oversee the receipt, accountability, return, or destruction of investigational products.

• Maintain regular communication with investigative sites.

• Document monitoring activities and findings through timely visit reports.

• Contribute to the development of protocols, CRFs, monitoring plans, and feasibility studies.

• Assist in the assessment and training of other Clinical Research Associates (CRAs) through accompanied site visits.

• Collaborate with sites, sponsors, and global study teams.

• Travel to investigative sites approximately 6–10 days each month.

⛳️ Requirements

• MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent) with a minimum of one year of experience as a Clinical Research Associate Level I; OR

• A four-year degree in medical, biological, physical, health, pharmacy, or a related field with at least two years of clinical research experience; OR

• A two-year college curriculum or equivalent education/training, preferably in nursing or life sciences, along with two years of experience as a Clinical Research Associate Level I.

• Strong understanding of clinical research principles and processes, GCP, ICH Guidelines, applicable FDA and/or EU regulations, local regulatory requirements, and Standard Operating Procedures (SOPs).

• Clinical research expertise across three to five therapeutic areas, or extensive knowledge of two to three therapeutic areas.

• Proficient in Microsoft Office, IxRS, and electronic data capture (EDC) systems.

• Excellent communication, organizational, time-management, interpersonal, initiative, and problem-solving abilities.

• Capability to work independently in a structured and methodical manner.

• Proficiency in spoken and written English.

• Fluency in the local languages of the countries under your responsibility.

• Valid current passport and driving license.

• Willingness to travel as required.

• Experience in full-service monitoring is PREFERRED.

🏝️ Benefits

• A collaborative and inclusive working environment.

• Opportunities for growth and career advancement.

• Chance to learn, grow, and shape the future of clinical research.

• Home-based remote work arrangement.

• Regional travel opportunities.

• Global collaboration with sites, sponsors, and study teams.