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Oncology Clinical Research Specialist
2 months ago
Objective: As an Oncology Clinical Research Specialist, you will be instrumental in the management and execution of Phase 1 and Phase 2 clinical studies. Your role will involve close collaboration with multidisciplinary teams to ensure compliance with study protocols, regulatory standards, and the highest quality benchmarks throughout the clinical research lifecycle.
Expected Travel: 50%
Key Responsibilities
- Study Initiation and Planning:
- Engage in feasibility assessments and site selection activities.
- Support the creation and evaluation of essential documentation, including informed consent forms and study manuals.
- Clinical Trial Monitoring:
- Conduct site qualification, initiation, interim monitoring, and close-out visits to ensure adherence to study protocols, Good Clinical Practice (GCP), and regulatory guidelines.
- Manage routine site communications, addressing site issues and providing necessary protocol training.
- Data Collection and Management:
- Oversee and assess clinical data to guarantee accuracy, completeness, and timeliness.
- Collaborate with data management teams to rectify data discrepancies and uphold data integrity throughout the trial.
- Regulatory Compliance:
- Assist in the preparation of regulatory submissions and support audits and inspections as required.
- Ensure that all clinical trial activities comply with relevant regulatory requirements and internal protocols.
- Collaboration and Communication:
- Build and maintain strong relationships with investigators, study coordinators, and other key stakeholders.
- Provide regular updates to internal teams and management regarding study progress, challenges, and resolutions.
To excel in this role, candidates must demonstrate the ability to perform each essential duty effectively. The qualifications listed below represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to fulfill the essential functions.
- Bachelor's degree in life sciences or a related discipline; advanced degrees (e.g., Master's, PhD) are preferred.
- A minimum of 2 years of experience as a Clinical Research Associate, with a strong preference for oncology experience.
- Preference for candidates located in the Chicago area.
- Proficient in understanding clinical trial protocols, GCP, regulatory requirements, EDC, EMR, eTMF, and CTMS.
- Exceptional organizational skills with meticulous attention to detail and the ability to prioritize effectively.
- Strong written and verbal communication skills, with excellent interpersonal abilities.
- Willingness to travel domestically and internationally as required, with typical CRA travel up to 50%, occasionally reaching 75% for specific project milestones.
The characteristics of the work environment described here are representative of those an employee may encounter while performing the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- May require prolonged periods of sitting or standing for 8+ hours daily while performing job duties.
For more information about Perspective Therapeutics, please visit our website.
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This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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