Health Decision is a specialty CRO that utilizes a broad expertise across Women’s Health research with adaptive design and adaptive operational capabilities to deliver medicines and diagnostics of value to women worldwide. We are seeking an experienced Clinical Research Associate to join our team. The CRA will be responsible for performing site monitoring activites for assigned clinical studies in accordance with the Task Order, protocol, standard operating procedures (SOPs), ICH guidelines and all applicable regulatory requirements.
- Responsible for performing on-site monitoring visits to ensure patient safety, GCP compliance and data integrity by confirming the site is conducting the study in accordance with the protocol, ICH guidelines, and applicable regulatory requirements
- Assists with investigator identification, evaluation and selection activities, as requested
- Performs pre-study site visits (PSSVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs) in accordance with the Task Order, protocol, study-specific monitoring plan, applicable SOPs, ICH guidelines and all applicable regulatory requirements.
- Conducts source document verification, performs drug accountability and reviews the investigator site file during on-site monitoring visits as outlined in the study-specific monitoring plan
- Responsible for building strong, collaborative relationship with investigators and staff at assigned clinical sites.
- Collaborates with assigned sites to develop and maintain a site-specific recruitment and retention plan; responsible for regularly reviewing this plan with the site during monitoring visits and ensuring the timely implementation of contingency plans ensure recruitment goals are met
- Serves as a point of contact for study-related questions and issues from study sites
- Responsible for providing study-specific training to the clinical site staff
- Generates confirmation letters, monitoring visit trip reports, and follow up letters in a timely manner for each monitoring visit
- Generates and assists in the closure of data queries, as appropriate
- Assists in the collection of follow-up data for serious adverse events, as requested
- Pro-actively identifies, documents, and assists in the resolution of issues relating to subject recruitment, study data quality and study conduct at assigned study sites
- Partners with Inhouse CRAs (IHCRAs) to ensure seamless management of assigned clinical sites. Frequently communicates with IHCRAs to share updates on assigned sites, discuss site issues and concerns, and agree actions for resolving issues and deficiencies at the site. Works with the IHCRAs to prepare for and follow-up of on-site monitoring visits by participating in pre-visit calls with IHCRAs and taking responsibility for the resolution of issues identified during on‑site visits that must be handled on‑site.
- Attends project team meetings, departmental meetings and meetings with line manager
- Performs tasks in internal and client-specific systems, as required
The successful candidate will hold a BS/BA degree in a scientific or health-related field with at least two years of clinical research monitoring experience. Prior experience in the conduct of clinical research including ICH-GCP requirements, drug/device development process, regulatory compliance, and study coordination with a working knowledge of medical terminology, FDA regulations and ICH guidelines. Strong interpersonal organizational skills, excellent written, oral communication and attention to detail. Solid understanding of Microsoft Office Suite.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.