Site Manager

**About Care Access**

Care Access is working to make the future of health better for all. **With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care.**We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, **and contribute to the medical breakthroughs of tomorrow.**

With programs like _Future of Medicine_, which makes advanced health screenings and research opportunities accessible to communities worldwide, and _Difference Makers_, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

**How This Role Makes a Difference**:
The Site Manager is responsible for overseeing the day-to-day activities at the site under the direction of the Region Manager. The Site Manager is responsible for ensuring delivery of enrollment goals while maintaining adherence to FDA regulations, ICH guidelines, and CARE SOPs in all aspects of conducting clinical trials. The Site Manager will manage the sites most challenging protocols (therapeutic areas and study designs) and those with Key Sponsors and CROs. The Site Manager conducts delegated clinical tasks and monitoring of research participants in accordance with Good Clinical Practices (GCP), ensuring protocol and regulatory compliance.

**How You'll Make An Impact**:

- Oversee the day to day activities (further defined below) at the site under the direction of the Region Manager
- Monitor and mentor all levels of CRC, RNs and CRCs to ensure complete understanding of Care Access processes, SOPs, and values, ensuring that they are successful during their transition to more demanding opportunities and responsibilities
- Obtain informed consent per Care Access Research SOP.
- Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
- Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
- Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
- Manage the sites most challenging protocols (therapeutic areas and study designs) and those with Key Sponsors and CROs.
- Act as a primary point of contact in the therapeutic field for Care Access Research
- Conducts delegated clinical tasks (RN specific) and monitoring of research participants in accordance with Good Clinical Practices (GCP), ensuring protocol and regulatory compliance.
- Clinical Tasks Include:

- Preparation and administration of Investigational Product (IP; study drug)
- Monitor participant for adverse reactions
- Perform phlebotomy and insert IV catheters
- Conduct delegated clinical procedures as required per protocol
- Prioritize activities with specific regard to protocol timelines
- Maintain adherence to Health Canada Division 5 regulations and ICH guidelines in all aspects of conducting clinical trials.
- Collaborate with PI to review and assess protocol (including amendments) for clarity, logístical feasibility, safety, inconsistencies, etc.
- Record data legibly and enter in real time on paper or e-source documents
- Accurately record study medication inventory, medication dispensation, and patient compliance.
- Resolve data management queries and correct source data within sponsor provided timelines
- Assist regulatory personnel with completion and filing of regulatory documents.
- Maintain the blinding of all study products where required.
- Enter all Quality issues into QMS and report protocol deviations to sponsor
- Maintain effective relationships with study participants and other Care Access personnel
- Interact in a positive, professional manner with patients, sponsor representatives, investigators, and Care Access personnel and management
- Ensure recruitment activities are optimized and all sites in the region are meeting their study enrollment goals
- Engage in continuous independent learning within the therapeutic area of responsibility

**The Expertise Required**:

- Excellent working knowledge of medical and research terminology
- Excellent working knowledge of federal regulations, good clinical practices (GCP)
- Understanding of issues affecting clinical research in the identified therapeutic area of expertise
- Ability and willingness to mentor and guide less experienced CRC as they develop and gain experience in all therapeutic areas
- Ability to communicate and work effectively with a diverse team of professionals
- Excellent organizational, prioritization and leadership skills a