CRA SSU – Monitoring and Regulatory

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

📋 Description

• Conducts site qualification, initiation, interim monitoring, management activities, and close-out visits (either onsite or remotely) while ensuring compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiological Practices (GPP), and protocol requirements.

• Utilizes judgment and experience to assess the overall performance of the site and its staff, offering recommendations for site-specific actions; promptly communicates/escalates critical issues to the project team and collaborates on action plans with appropriate guidance.

• Maintains up-to-date knowledge of ICH/GCP Guidelines or other relevant guidance, applicable regulations, and company SOPs/processes.

• Confirms that the process of obtaining informed consent has been properly executed and documented for each subject/patient, as needed.

• Exhibits diligence in safeguarding the confidentiality of each subject/patient.

• Evaluates factors that could impact the safety of subjects/patients and the integrity of clinical data at an investigator/physician site, including protocol deviations/violations and pharmacovigilance concerns.

• For the Clinical Monitoring/Site Management Plan (CMP/SMP): Evaluates site processes.

• Performs Source Document Review of relevant site documents and medical records.

• Ensures that the required clinical data entered in the case report form (CRF) is accurate and complete.

• Applies query resolution techniques both remotely and onsite, offering guidance to site staff as needed, and drives query resolution to completion within agreed timelines.

• Utilizes available hardware and software to facilitate the effective execution of the clinical project data review and capture.

• Ensures site adherence to electronic data capture requirements.

• May oversee investigational product (IP) inventory, reconciliation, and assess storage and security protocols.

• Confirms that the investigational product has been dispensed and administered to subjects/patients in accordance with the protocol.

• Identifies issues or risks related to blinded or randomized information concerning the investigational product.

• Applies knowledge of GCP/local regulations and organizational procedures to guarantee that the investigational product is correctly (re)labelled, imported, and released/returned.

• Regularly reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.

• Reconciles the contents of the ISF with the Trial Master File (TMF).

• Ensures that the investigator/physician site is informed about the necessity of archiving essential documents per local guidelines and regulations.

• Records activities through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents according to SOPs and the Clinical Monitoring Plan/Site Management Plan.

• Aids in strategies for subject/patient recruitment, retention, and awareness.

• Inputs data into tracking systems as necessary to monitor all observations, ongoing statuses, and assigned action items until resolution.

• For assigned responsibilities, comprehends project scope, budgets, and timelines; manages site-level activities/communication to ensure that project objectives, deliverables, and timelines are achieved.

• Must be adaptable, with the oversight of the Lead CRA, to shifting priorities to meet goals/targets.

• May serve as the primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA).

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or a comparable combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.

• Must possess proficient computer skills and be open to adopting new technologies.

• Exceptional communication, presentation, and interpersonal skills.

• Ability to manage required travel of up to 75% regularly.

🏝️ Benefits

• We are dedicated to fostering the development of our people through career advancement and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition; and a comprehensive rewards program.

• We are committed to cultivating an inclusive culture – where you can genuinely be yourself.