Responsibilities
- Coordinate and manage clinical trial activities.
- Ensure adherence to protocols, standard operating procedures, and regulatory requirements.
- Monitor and document trial progress, including data collection and reporting.
- Maintain accurate and up-to-date trial documentation.
- Communicate effectively with study sites, sponsors, and other stakeholders.
- Conduct site visits to assess compliance and provide training.
- Manage and resolve any issues or discrepancies that arise during the trial.
- Prepare and submit regulatory documents and reports.
- Ensure the safety and well-being of trial participants.
- Collaborate with cross-functional teams to achieve trial objectives.
- Participate in the development and implementation of trial plans.
- Provide input on the design and conduct of clinical trials.
- Review and approve trial-related documents and reports.
- Conduct risk assessments and implement mitigation strategies.
- Ensure the integrity and confidentiality of trial data.
- Provide guidance and mentorship to junior staff.
- Stay up-to-date with industry trends and regulatory changes.
- Contribute to the development of standard operating procedures.
- Participate in the development of training materials and programs.
- Assist in the preparation of regulatory submissions and responses.
- Conduct audits and inspections to ensure compliance with regulations.
- Manage and resolve any adverse events or safety issues.
- Provide input on the selection and management of vendors and suppliers.
- Participate in the development and implementation of quality management systems.
Nice to Have
- Master's degree in a related field.
- Certification in clinical research or a related field.
- Experience with global clinical trials.
- Fluency in multiple languages.
- Experience with Phase I-IV clinical trials.
- Knowledge of specific therapeutic areas.
- Experience with clinical trial budgeting and contracting.
- Familiarity with clinical trial supply management.
- Experience with clinical trial data analysis and reporting.
- Knowledge of clinical trial project management tools.
- Experience with clinical trial recruitment and retention strategies.
- Familiarity with clinical trial regulatory submissions.
- Experience with clinical trial risk management.
- Knowledge of clinical trial quality assurance and control.
- Experience with clinical trial data management systems.
- Familiarity with clinical trial monitoring and auditing tools.
- Experience with clinical trial site selection and management.
- Knowledge of clinical trial data integrity and security.
- Experience with clinical trial regulatory compliance.
- Familiarity with clinical trial project management methodologies.
Compensation
Competitive salary and benefits package.
Work Arrangement
On-site with potential for travel.
Team
Collaborative team environment with opportunities for professional growth.
Location
Multiple locations across the United States.
Travel Requirements
Up to 50% travel may be required for site visits and meetings.
Education
Bachelor's degree in a related field, or equivalent experience.
Experience
Proven experience in clinical research, with at least 2 years for Associate II and 5 years for Senior Associate.
Certifications
Certification in clinical research or a related field is preferred.
Skills
- Strong organizational and time management skills.
- Excellent communication and interpersonal skills.
- Ability to work independently and in a team environment.
- Attention to detail and accuracy.
- Problem-solving and decision-making skills.
- Ability to manage multiple tasks and priorities.
Knowledge
- Knowledge of clinical trial regulations and guidelines.
- Experience with electronic data capture (EDC) systems.
- Knowledge of Good Clinical Practice (GCP) guidelines.
- Familiarity with regulatory requirements and standards.
- Knowledge of clinical trial design and methodology.
- Knowledge of data integrity and confidentiality standards.
Responsibilities
- Coordinate and manage clinical trial activities.
- Ensure adherence to protocols, standard operating procedures, and regulatory requirements.
- Monitor and document trial progress, including data collection and reporting.
- Maintain accurate and up-to-date trial documentation.
- Communicate effectively with study sites, sponsors, and other stakeholders.
Qualifications
- Bachelor's degree in a related field, or equivalent experience.
- Proven experience in clinical research, with at least 2 years for Associate II and 5 years for Senior Associate.
- Knowledge of clinical trial regulations and guidelines.
- Experience with electronic data capture (EDC) systems.
- Strong organizational and time management skills.
Preferred Qualifications
- Master's degree in a related field.
- Certification in clinical research or a related field.
- Experience with global clinical trials.
- Fluency in multiple languages.
- Experience with Phase I-IV clinical trials.
Visa sponsorship may be available for qualified candidates.
