Freelance Senior Clinical Research Associate - up to 0.1 FTE - Latvia

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise‑build‑operate model across the complete product lifecycle.

We are in need of an experienced SCRA, based in Latvia, to support us with oversight visit allocation on an ad‑hoc basis, as required by the study. The Senior Clinical Research Associate position is responsible for clinical monitoring for assigned protocols and investigational sites. The role is responsible for ensuring that studies are conducted and documented in accordance with the study protocol, standard operating procedures, Good Clinical Practices (GCP) and other applicable regulatory requirements.

Responsibilities include:

• Conducting all types of monitoring, and co‑monitoring visits and associated monitoring activities for assigned clinical sites both in person and remote.
• Monitoring report writing and completion within required SOP and local regulatory parameters.
• Performing study start‑up activities in accordance with local practice, including site identification and feasibility activities, collection and preparation of site essential documents, Ethics Committee submissions, and other site set‑up activities.
• Supporting development of study specific documentation related to monitoring activities as assigned.
• Managing site personnel and training on protocol requirements, proper source documentation procedures compliance, and case report completion requirements.
• Reviewing source document and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
• Managing investigational supplies as assigned, including monitoring and documenting investigational supplies dispensing, inventory, and reconciliation.
• Monitoring assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities and any other activity at the site that contributes to proper conduct of the clinical trial per protocol, and regulatory requirements.
• Reviewing and overseeing regulatory documentations for accuracy and completeness and supporting assigned clinical sites with any regulatory concerns as appropriate.
• Communicating with assigned clinical sites, investigators, site personnel, client personnel, and any other cross‑functional team member involved in the assigned clinical trials to address any study needs related to the monitoring and site management activities as assigned.
• Participating in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial.

Necessary Skills And Abilities:

• Excellent verbal, written communication skills and interpersonal and presentation skills.
• Excellent computer skills with experience using Microsoft Office applications.
• Electronic data capture (EDC), CTMS, IVRS, and eTMF experience.
• Knowledge of applicable local law, local regulatory requirements and regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Strong organizational skills and attention to details.
• Ability to prioritize and plan workload.

Educational Requirements:

• Bachelor's degree or equivalent combination of education and experience.

Experience Requirements:

• More than 5 years of experience as a Clinical Research Associate.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.

ProPharma supports remote working but also recognises the value that comes from in-person collaboration. We encourage new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager.