Postúlate en Kit Empleo: kitempleo.com.co/empleo/1aavtx

CRA SSU - Experience in monitoring and regulatory - Sponsor dedicated - Colombia Home Based

Job Description: Senior Clinical Research Associate responsible for site qualification, monitoring, and site management for clinical trials conducted in Colombia on a home-based, sponsor‑dedicated arrangement.

Job Responsibilities

- Perform site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site‑specific actions; immediately communicate/escalate serious issues to the project team and with guidance develop action plans. Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrate diligence in protecting the confidentiality of each subject/patient. Assess factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- For the Clinical Monitoring/Site Management Plan (CMP/SMP): assess site processes; conduct source document review of appropriate site source documents and medical records; verify required clinical data entered in the case report form (CRF) is accurate and complete; apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines; utilize available hardware and software to support the effective conduct of the clinical project data review and capture; verify site compliance with electronic data capture requirements.
- May perform investigational product (IP) inventory, reconciliation and reviews of storage and security. Verify the IP has been dispensed and administered to subjects/patients according to the protocol. Verify issues or risks associated with blinded or randomized information related to IP. Apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
- Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconcile contents of the ISF with the Trial Master File (TMF). Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Document activities via confirmation letters, follow‑up letters, trip reports, communication logs,



and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Support subject/patient recruitment, retention and awareness strategies. Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
- For assigned activities, understand project scope, budgets, and timelines; manage site‑level activities/communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals/targets.
- May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensure all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
- Prepare for and attend Investigator Meetings and/or sponsor face‑to‑face meetings. Participate in integral clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to project specific requirements.
- Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow‑up actions.
- For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include: site support throughout the study lifecycle from site identification through close‑out; knowledge of local requirements for real world late phase study designs; chart abstraction activities and data collection; collaboration with Sponsor affiliates, medical science liaisons and local country staff.

Qualifications

- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.

US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further,



a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk‑based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution: Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.

#J-18808-Ljbffr

Postúlate en Kit Empleo: kitempleo.com.co/empleo/1aavtx

📌 CRA SSU - Experience in monitoring and regulatory - Sponsor dedicated - Colombia Home Based (Bogotá)
🏢 Syneos Health
📍 Bogotá