Senior Clinical Research Associate

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

📋 Description

• May assist in the creation of study tools, materials, and documentation for clinical trials.

• May offer mentoring, training, and co-monitoring for junior CRAs and other members of the clinical team.

• May support the RFP process.

• Prepare and conduct all onsite and off-site/remote monitoring visit activities across various protocols, including all necessary study visit types (SQV, SIV, IMV, and COV), in accordance with Good Clinical Practice (GCP), Protocol, relevant regulations, and Sponsor requirements under the guidance of experienced personnel.

• Accurately document observations in site visit reports and follow-up letters within the timelines specified by Rho’s procedural documents and the applicable clinical monitoring plan.

• Prepare (if necessary) and maintain Investigator Site Files (ISF), along with managing site binders and Trial Master File (TMF) documents.

• May assist with payment processes, including liaising with sites and reviewing site and patient data for invoiced visits.

• Help in the proper identification and management of Adverse Events (AE), Serious Adverse Events (SAE), and pregnancy reporting procedures.

• Verify and ensure proper handling of Investigational Medicinal Products (IMP) at the site and conduct drug accountability.

• Assist in planning and executing Country and Site Feasibility, including evaluating potential risks and challenges, selecting study sites, and conducting pre-study visits.

• Aid in the selection of study-specific vendors and carry out vendor assessments.

• Support negotiations and the execution of Investigator/Institution contracts.

• May assist in the preparation of documents for submission to Ethics Committees, Competent Authorities, and other relevant bodies (as applicable), including communication with Sponsors, EC/CA, and other involved parties.

• Provide mentoring, training, and co-monitoring for junior CRAs and other clinical team members.

• May assist the Clinical Team Lead and Project Management tasks on assigned studies as requested (e.g., study-specific process development, trip report review, newsletter creation, leading CRA project team calls, etc.).

• May conduct sign-off visits to evaluate the competency of other CRAs.

• May represent the organization by attending and presenting at meetings and conferences, including Investigator Meetings.

• May participate in the interview and selection process for CRAs.

⛳️ Requirements

• Bachelor’s degree, ideally in a life science, nursing, pharmacy, or a related field.

• Registered Nursing certification or an equivalent relevant formal academic/vocational qualification (such as LPN), combined with at least 2 years of clinical monitoring experience and demonstrated knowledge of clinical monitoring, may be accepted in lieu of a Bachelor’s degree.

• 2 years of on-site monitoring experience within the CRO, pharmaceutical, or biotechnology sector.

• Fluent in English and the local language.

• Proficient understanding of ICH-GCP and country-specific clinical monitoring guidelines.

• Proven skills in clinical monitoring.

• Demonstrated comprehension of medical and therapeutic area knowledge, as well as medical terminology relevant to areas of expertise.

• Average travel requirement is expected to be 80%.

• Willingness to travel domestically and internationally as necessary.

🏝️ Benefits

• Comprehensive health insurance plans.

• Opportunities for professional development and further education.

• Flexible work arrangements.

• Competitive salary and performance-based bonuses.