Game-changing therapies that make an impactful difference for cancer patients and the clinicians who treat them.
Clinical Research Associate II
Location
North Carolina
Posted
41 days ago
Salary
0
Seniority
Mid Level
Job Description
Clinical Research Associate II
Perspective Therapeutics
• Participate in study feasibility assessments, and site selection processes • Assist in the preparation and review of essential documents such as informed consent forms (ICFs) and study manuals • Conduct site qualification, site initiation, interim monitoring, and close-out visits • Regularly review Investigator Site Files (ISF) to assist in maintaining site audit readiness • Perform routine site communication, including resolving site issues and providing protocol training as necessary • Contribute to development and delivery of CRA training materials • Mentor and support junior CRAs and newly onboarded CRAs • Review study documents including the Clinical Monitoring Plan and Investigator Site File documents • Participate in trial risk management meetings and procedures • Monitor and review clinical data to ensure accuracy, completeness, and timeliness • Work closely with data management teams to resolve data discrepancies and ensure data integrity throughout the trial • Assist in the preparation of regulatory submissions and support inspections/audits as needed • Foster strong relationships with investigators, study coordinators, and other key stakeholders • Provide regular updates to internal teams and management regarding study progress, issues, and resolutions
Job Requirements
- Bachelor’s degree in life sciences or a related field; advanced degree (e.g., Master’s, PhD) preferred
- Minimum 2 years oncology experience (or commensurate)
- Proficiency in understanding clinical trial protocols, GCP, regulatory requirements, EDC, EMR, eTMF, and CTMS
- Strong organizational skills with attention to detail and the ability to prioritize tasks effectively
- Ability to effectively and efficiently perform source data verification (SDV) whether remotely or onsite
- Ability to identify protocol deviations and effectively identify root cause and assist sites in implementing corrective or preventative actions
- Excellent communication and interpersonal skills, both written and verbal
- Ability to travel domestically and internationally as required.
- Ability to perform the CRA role without significant onboarding or training
- Can manage complex protocols/sites
Benefits
- Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment
- Prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws
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• Coordinates investigator/ site feasibility and identification process, as well as study startup. • Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. • Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. • Manages Monitors in the query resolution process, including Central Monitoring observations. • Coordinates safety information flow and protocol/process deviation reporting. • Performs clinical supplies management with vendors on a country and regional level. • Ensures study-specific and corporate tracking systems are updated in a timely manner. • Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. • Coordinates planning of supervised monitoring visits and conducts the visits. • Manages the project team in site contracting and payments. • Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. • Ensures ongoing evaluation of data integrity and compliance at a country/regional level. • Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. • Oversees project team in CAPA development and implementation. • Coordinates project team in process deviations review, management and reporting. • Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. • Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. • Delivers trainings and presentations at Investigator Meetings. • Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits. • Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. • Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. • Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. • Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. • Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. • Ensures data integrity and compliance at a site level. • Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. • Conducts project-specific training of site Investigators. • Supports preparation of draft regulatory and ethics committee submission packages.
• Coordinates investigator/ site feasibility and identification process, as well as study startup. • Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. • Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. • Manages Monitors in the query resolution process, including Central Monitoring observations. • Coordinates safety information flow and protocol/process deviation reporting. • Performs clinical supplies management with vendors on a country and regional level. • Ensures study-specific and corporate tracking systems are updated in a timely manner. • Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. • Coordinates planning of supervised monitoring visits and conducts the visits. • Manages the project team in site contracting and payments. • Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. • Ensures ongoing evaluation of data integrity and compliance at a country/regional level. • Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. • Oversees project team in CAPA development and implementation. • Coordinates project team in process deviations review, management and reporting. • Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. • Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. • Delivers trainings and presentations at Investigator Meetings. • Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits. • Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. • Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. • Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. • Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. • Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. • Ensures data integrity and compliance at a site level. • Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. • Conducts project-specific training of site Investigators. • Supports preparation of draft regulatory and ethics committee submission packages.
Specialized Research Analyst
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Role Description Provides high quality customer service to merchants by responding to inquiries regarding the support of Merchant Credit Card processing as well as other areas as assigned. Responds to telephone inquiries, requests and problems from merchants. Troubleshoots, diagnoses and provides merchants with solutions to resolve problems with service, authorization and credit card processing terminals. Communicates applicable policies, procedures and practices to merchants. Requests exceptions to policies and procedures on behalf of merchant as appropriate, within established limits. Qualifications - High school diploma or equivalent - Typically one to two years of customer service experience Requirements - Thorough knowledge of products, services, problem resolution practices and procedures, applicable regulations, systems and procedures - Effective telephone, interpersonal and verbal communication skills - Strong problem-solving and negotiation skills as well as the ability to handle difficult customer calls - Ability to identify and resolve/escalate complex problems - Proficient computer navigation skills using a variety of software packages including Microsoft Office applications - Proven commitment to high quality customer service - Effective time management skills to maximize the number of clients that can be assisted while maintaining a high level of customer service - Elavon experience HIGHLY PREFERRED Benefits - Healthcare (medical, dental, vision) - Basic term and optional term life insurance - Short-term and long-term disability - Pregnancy disability and parental leave - 401(k) and employer-funded retirement plan - Paid vacation (from two to five weeks depending on salary grade and tenure) - Up to 11 paid holiday opportunities - Adoption assistance - Sick and Safe Leave accruals of one hour for every 30 worked, up to 80 hours per calendar year unless otherwise provided by law
Role Description Provides high quality customer service to merchants by responding to inquiries regarding the support of Merchant Credit Card processing as well as other areas as assigned. - Responds to telephone inquiries, requests and problems from merchants. - Troubleshoots, diagnoses and provides merchants with solutions to resolve problems with service, authorization and credit card processing terminals. - Communicates applicable policies, procedures and practices to merchants. - Requests exceptions to policies and procedures on behalf of merchant as appropriate, within established limits. Qualifications - High school diploma or equivalent - Typically one to two years of customer service experience Requirements - Thorough knowledge of products, services, problem resolution practices and procedures, applicable regulations, systems and procedures - Effective telephone, interpersonal and verbal communication skills - Strong problem-solving and negotiation skills as well as the ability to handle difficult customer calls - Ability to identify and resolve/escalate complex problems - Proficient computer navigation skills using a variety of software packages including Microsoft Office applications - Proven commitment to high quality customer service - Effective time management skills to maximize the number of clients that can be assisted while maintaining a high level of customer service - Elavon experience HIGHLY PREFERRED Benefits - Healthcare (medical, dental, vision) - Basic term and optional term life insurance - Short-term and long-term disability - Pregnancy disability and parental leave - 401(k) and employer-funded retirement plan - Paid vacation (from two to five weeks depending on salary grade and tenure) - Up to 11 paid holiday opportunities - Adoption assistance - Sick and Safe Leave accruals of one hour for every 30 worked, up to 80 hours per calendar year unless otherwise provided by law


