Medix
You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
Our client is looking for a Clinical Site Director responsible for driving operational performance at the research site. The position requires oversight to ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, and FDA guidelines while adhering to company policies.
Key Responsibilities
Overall site management with a focus on performance, efficiencies, patient safety, and protocol compliance. Collaborate with department leaders to coordinate delivery expectations and meet study milestones. Review performance dashboards to oversee site and patient activities. Oversee resource allocations, site assignments, and team performance to ensure study deliverables. Assist with training regarding protocol specificities and timelines for the study. Ensure adherence to SOPs, GCP, FDA regulations, and company policies. Oversee site staff and assess study-specific process and training compliance. Support the execution of corrective action plans at site and study levels. Manage people activities including hiring, appraisals, and termination meetings. Manage payroll, absence tracking, new hire orientation, and training as needed. Collaborate with investigators to ensure patient safety and meet client goals. Utilize strategic thinking and problem-solving to propose risk mitigations. Participate and present in management or site meetings. Perform additional duties as required. Qualifications
Bachelor's degree and 5+ years of clinical research experience or equivalent. 2+ years of management experience required. Clinical research site management experience highly preferred. Bi-lingual proficiency in English and Spanish is a plus. Skills
Proficiency with Microsoft applications and electronic health records. Strong organizational, time management, and project management skills. Well-developed written and verbal communication skills. Interpersonal and listening skills; ability to work well independently and with others. Ability to handle multiple tasks and adapt to changes in workloads and priorities. Professional, self-motivated, with a strong work ethic. High degree of integrity and dependability. Ability to work under minimal supervision, identify problems, and implement solutions. Handle sensitive information confidentially and professionally, complying with HIPAA. Benefits
Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances). Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)). 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1). Short Term Disability Insurance. Term Life Insurance Plan.
Required Employment / Compliance Language
Our client is an Equal Opportunity Employer that values and respects a diverse and inclusive workforce. It is company policy to recruit, hire, train, and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. Diversity and inclusion drive the success of our client's operations.
* We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
Medix Overview:
With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we're dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.
* As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
Job Summary
Our client is looking for a Clinical Site Director responsible for driving operational performance at the research site. The position requires oversight to ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, and FDA guidelines while adhering to company policies.
Key Responsibilities
Overall site management with a focus on performance, efficiencies, patient safety, and protocol compliance. Collaborate with department leaders to coordinate delivery expectations and meet study milestones. Review performance dashboards to oversee site and patient activities. Oversee resource allocations, site assignments, and team performance to ensure study deliverables. Assist with training regarding protocol specificities and timelines for the study. Ensure adherence to SOPs, GCP, FDA regulations, and company policies. Oversee site staff and assess study-specific process and training compliance. Support the execution of corrective action plans at site and study levels. Manage people activities including hiring, appraisals, and termination meetings. Manage payroll, absence tracking, new hire orientation, and training as needed. Collaborate with investigators to ensure patient safety and meet client goals. Utilize strategic thinking and problem-solving to propose risk mitigations. Participate and present in management or site meetings. Perform additional duties as required. Qualifications
Bachelor's degree and 5+ years of clinical research experience or equivalent. 2+ years of management experience required. Clinical research site management experience highly preferred. Bi-lingual proficiency in English and Spanish is a plus. Skills
Proficiency with Microsoft applications and electronic health records. Strong organizational, time management, and project management skills. Well-developed written and verbal communication skills. Interpersonal and listening skills; ability to work well independently and with others. Ability to handle multiple tasks and adapt to changes in workloads and priorities. Professional, self-motivated, with a strong work ethic. High degree of integrity and dependability. Ability to work under minimal supervision, identify problems, and implement solutions. Handle sensitive information confidentially and professionally, complying with HIPAA. Benefits
Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances). Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)). 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1). Short Term Disability Insurance. Term Life Insurance Plan.
Required Employment / Compliance Language
Our client is an Equal Opportunity Employer that values and respects a diverse and inclusive workforce. It is company policy to recruit, hire, train, and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. Diversity and inclusion drive the success of our client's operations.
* We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
Medix Overview:
With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we're dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.
* As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.