Clinical Research Associate II - North Carolina, East Coast
Objective
As a Clinical Research Associate II (CRA II) specializing in oncology, you will play a crucial role in the execution and management of Phase 1, Phase 2, and Phase 3 clinical trials. You will collaborate closely with cross-functional teams to ensure adherence to protocols, regulatory requirements, and high-quality standards throughout the clinical trial process.
• *** Qualified Candidates need to live in or near North Carolina ******
Essential Functions
• Study Initiation and Planning:
• 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
• Clinical Trial Monitoring:
• Conduct site qualification, site initiation, interim monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory guidelines
• 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
• Leadership:
• 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
• Identify, develop and implement process improvement initiatives to enhance monitoring quality and mitigate trial risks
• Data Collection and Management:
• 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
• Regulatory Compliance:
• Assist in the preparation of regulatory submissions and support inspections/audits as needed
• Ensure that all clinical trial activities are conducted in accordance with applicable regulatory requirements and internal procedures
• Collaboration and Communication:
• 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
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience
• 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)
Knowledge / Skill / Ability
• 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. Typical CRA travel is up to 50%, however, at times can go up to 75% for certain project deliverables (e.g. database lock, etc.)
• Ability to perform the CRA role without significant onboarding or training
• Can manage complex protocols/sites
• Grows to lead other CRAs
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and 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.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.
As a Clinical Research Associate II (CRA II) specializing in oncology, you will play a crucial role in the execution and management of Phase 1, Phase 2, and Phase 3 clinical trials. You will collaborate closely with cross-functional teams to ensure adherence to protocols, regulatory requirements, and high-quality standards throughout the clinical trial process.
• *** Qualified Candidates need to live in or near North Carolina ******
Essential Functions
• Study Initiation and Planning:
• 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
• Clinical Trial Monitoring:
• Conduct site qualification, site initiation, interim monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory guidelines
• 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
• Leadership:
• 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
• Identify, develop and implement process improvement initiatives to enhance monitoring quality and mitigate trial risks
• Data Collection and Management:
• 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
• Regulatory Compliance:
• Assist in the preparation of regulatory submissions and support inspections/audits as needed
• Ensure that all clinical trial activities are conducted in accordance with applicable regulatory requirements and internal procedures
• Collaboration and Communication:
• 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
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience
• 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)
Knowledge / Skill / Ability
• 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. Typical CRA travel is up to 50%, however, at times can go up to 75% for certain project deliverables (e.g. database lock, etc.)
• Ability to perform the CRA role without significant onboarding or training
• Can manage complex protocols/sites
• Grows to lead other CRAs
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and 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.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.