What are the responsibilities and job description for the Senior Clinical Research Associate position at Pedestal Health?
About Pedestal Health
Pedestal Health (formerly Target RWE) combines deep health system partnerships, longitudinal data curation at scale, and modern study design to build continuous, high-quality evidence for life sciences organizations. The company partners with pharmaceutical and biotech companies, providers and payers to generate rigorous, multimodal evidence that supports clinical, regulatory and strategic decision-making across the full lifecycle of care. Pedestal Health is committed to advancing medical decision making to improve outcomes for patients. Pedestal Health is a Highlander Health company. Learn more at pedestalhealth.com.
The Role
Pedestal Health is seeking a Senior Clinical Research Associate to conduct site management and data monitoring of assigned clinical sites, ensuring all activities are conducted in accordance with applicable Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs). In addition to core monitoring responsibilities, the Senior CRA serves as a mentor to other CRAs and as a technical subject matter expert within the organization.
What You’ll Do
Pedestal Health is an equal opportunity employer and seeks candidates from diverse backgrounds and abilities.
Pedestal Health (formerly Target RWE) combines deep health system partnerships, longitudinal data curation at scale, and modern study design to build continuous, high-quality evidence for life sciences organizations. The company partners with pharmaceutical and biotech companies, providers and payers to generate rigorous, multimodal evidence that supports clinical, regulatory and strategic decision-making across the full lifecycle of care. Pedestal Health is committed to advancing medical decision making to improve outcomes for patients. Pedestal Health is a Highlander Health company. Learn more at pedestalhealth.com.
The Role
Pedestal Health is seeking a Senior Clinical Research Associate to conduct site management and data monitoring of assigned clinical sites, ensuring all activities are conducted in accordance with applicable Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs). In addition to core monitoring responsibilities, the Senior CRA serves as a mentor to other CRAs and as a technical subject matter expert within the organization.
What You’ll Do
- Conduct remote site selection visits (PSVs) to evaluate whether facilities and staff are adequate for conducting the study.
- Conduct remote site initiation visits (SIVs) to ensure sites and study staff are adequately trained and prepared to conduct the study.
- Verify that investigator(s) and study personnel are conducting the study in accordance with the protocol, GCP, and applicable regulatory requirements to protect the rights and ensure the ethical treatment of human subjects.
- Perform monitoring activities per the monitoring plan, including verification of source documents, informed consent review, site communications, and follow-up on data anomalies.
- Review the accuracy and completeness of site records, including essential documents, query resolution, and other study documentation.
- Ensure complete and accurate reporting and documentation of all monitoring activities.
- Assist with site start-up activities, including developing PSV/SIV presentation materials and supporting the Regulatory and Site Contracting teams in the collection and review of regulatory documents.
- Review and contribute to study plans and procedures, including the Monitoring Plan, Trial Management Plan, and Risk Plan.
- Travel to conduct on-site visits as needed. This position assumes the bulk of monitoring will be conducted remotely, but travel up to 25% may be required.
- Perform other duties as assigned.
- Act as a mentor and role model for other Clinical Research Associates.
- Act as a technical subject matter expert and point of contact for management and other departments.
- Bachelor's degree preferred, preferably in science or a related field, with 5 years of CRA or advanced clinical data experience.
- Substantial site management experience, or equivalent experience in clinical research and/or clinical studies.
- Ability to handle complex problems regularly, with a wide latitude for independent judgment.
- Solid understanding of clinical research and clinical studies methodology and terminology.
- Excellent written and verbal communication skills.
- Excellent Microsoft Office skills, along with computer data acquisition and report-writing ability.
- Ability to interact effectively with all levels of internal and external contacts.
- Ability to independently set and manage multiple priorities and evaluate unpredictable scenarios to achieve project timelines and deliverables.
- An equivalent combination of education and experience will be considered.
- Ability to work in a hybrid environment based in Research Triangle Park, NC (3 days in office, 2 days remote). This position assumes the bulk of monitoring will be conducted remotely, but travel up to 25% may be required.
- Certified Clinical Research Associate (CCRA) certification.
- Real-world evidence or Phase IV experience.
- Experience managing studies in REDCap Cloud highly desirable.
- Hybrid work arrangement, with regular onsite collaboration at a Pedestal Health office
- Comprehensive health, dental, and vision coverage
- 401(k) with company match
- Generous PTO and paid parental leave
Pedestal Health is an equal opportunity employer and seeks candidates from diverse backgrounds and abilities.