Director of Cardiovascular Research Administration - Baylor Scott & White Health
Plano, TX
About the Job
JOB SUMMARY
Director of Cardiovascular Research Administration is responsible for planning, directing, and coordinating the administrative operations of the clinical research function for Baylor Scott and White Health (BSWH), which includes clinical research support activities, compliance duties, special projects, and other general operations activities. Develops, implements, and communicates research operational policies, procedures, and processes to support the operations of the BSWH clinical research function, including research investigation projects, grant proposals, clinical trials office, data collection processes, and clinical documentation practices. Plans, organizes, controls, and coordinates research programs and projects, ensuring that the appropriate resources and processes are in place and project scope, timeframe, and budget requirements are met. Ensures compliance with all applicable legal, regulatory, and medical standards impacting BSWH research activities. Interacts with senior leadership, internal departments, and external stakeholders to enable, facilitate, and support BSWH research and clinical trial activities.
A system Director translates and implements strategic plans and objectives for area of responsibility. Makes final decisions on operational matters and ensures achievement of objectives. Recommends policies and organizational changes for area. Plans and executes projects and initiatives that meet annual objectives. Erroneous decisions at this level tend to have negative impact on the success of the area, business unit, and possibly the overall organization's operations. Plans and directs the operations of a department or area, with responsibility for staffing, processes, budgets, and costs of the unit. Leads and advises subordinate(s) to meet schedules, resolve technical problems, and monitor performance. Has a larger, more complex organization or functional area than a manager. Often has one or more managers or supervisors reporting to the role.
ESSENTIAL FUNCTIONS OF THE ROLE
1. Directs clinical research for assigned area of responsibility for BSWH.
2. Recommends and implements strategic and operational plans and priorities for clinical research aligned to BSWH overall business objectives.
3. Directs, assigns, and reviews clinical research conducted by teams including research nurses, research coordinators, research assistants and technicians, and other research staff and partners.
4. Leads the research grant application process, budget negotiation, and pre-award research and procedures.
5. Ensures compliance with all applicable federal, state, and local regulations regarding research.
6. Leads and coordinates pre- and post-award procedures with the clinical trials office.
7. Collaborates with business development and other stakeholders on the placement of clinical trials.
8. Leads phase I through IV clinical trials related to pharmaceutical products and devices, both investigational and marketed.
9. Oversees all aspects of clinical trials from study design through study termination.
10. Provides coordinator and investigator education on regulatory obligations of clinical investigators and good clinical practices.
KEY SUCCESS FACTORS
1. Bachelor’s degree in healthcare, business, public health, or related field. Master’s degree preferred.
2. 5+ years of experience in clinical research leadership or related area at a healthcare, academic, not-for-profit, or government organization.
3. 1+ years of experience in a leadership role.
4. Knowledge of complex clinical services and research environment.
5. Research certification preferred, such as Association of Clinical Research Professional (ACRP) or Certified Clinical Research Professional (CCRP).
6. Knowledge of guidelines, standards, and regulatory requirements related to research clinical trials.
7. Knowledge of research systems including electronic health records.
BENEFITS
Our competitive benefits package includes the following
- Immediate eligibility for health and welfare benefits
- 401(k) savings plan with dollar-for-dollar match up to 5%
- Tuition Reimbursement
- PTO accrual beginning Day 1
Note: Benefits may vary based upon position type and/or level
QUALIFICATIONS
- EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification
- EXPERIENCE - 5 Years of Experience
As a health care system committed to improving the health of those we serve, we are asking our employees to model the same behaviours that we promote to our patients. As of January 1, 2012, Baylor Scott & White Health no longer hires individuals who use nicotine products. We are an equal opportunity employer committed to ensuring a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Director of Cardiovascular Research Administration is responsible for planning, directing, and coordinating the administrative operations of the clinical research function for Baylor Scott and White Health (BSWH), which includes clinical research support activities, compliance duties, special projects, and other general operations activities. Develops, implements, and communicates research operational policies, procedures, and processes to support the operations of the BSWH clinical research function, including research investigation projects, grant proposals, clinical trials office, data collection processes, and clinical documentation practices. Plans, organizes, controls, and coordinates research programs and projects, ensuring that the appropriate resources and processes are in place and project scope, timeframe, and budget requirements are met. Ensures compliance with all applicable legal, regulatory, and medical standards impacting BSWH research activities. Interacts with senior leadership, internal departments, and external stakeholders to enable, facilitate, and support BSWH research and clinical trial activities.
A system Director translates and implements strategic plans and objectives for area of responsibility. Makes final decisions on operational matters and ensures achievement of objectives. Recommends policies and organizational changes for area. Plans and executes projects and initiatives that meet annual objectives. Erroneous decisions at this level tend to have negative impact on the success of the area, business unit, and possibly the overall organization's operations. Plans and directs the operations of a department or area, with responsibility for staffing, processes, budgets, and costs of the unit. Leads and advises subordinate(s) to meet schedules, resolve technical problems, and monitor performance. Has a larger, more complex organization or functional area than a manager. Often has one or more managers or supervisors reporting to the role.
ESSENTIAL FUNCTIONS OF THE ROLE
1. Directs clinical research for assigned area of responsibility for BSWH.
2. Recommends and implements strategic and operational plans and priorities for clinical research aligned to BSWH overall business objectives.
3. Directs, assigns, and reviews clinical research conducted by teams including research nurses, research coordinators, research assistants and technicians, and other research staff and partners.
4. Leads the research grant application process, budget negotiation, and pre-award research and procedures.
5. Ensures compliance with all applicable federal, state, and local regulations regarding research.
6. Leads and coordinates pre- and post-award procedures with the clinical trials office.
7. Collaborates with business development and other stakeholders on the placement of clinical trials.
8. Leads phase I through IV clinical trials related to pharmaceutical products and devices, both investigational and marketed.
9. Oversees all aspects of clinical trials from study design through study termination.
10. Provides coordinator and investigator education on regulatory obligations of clinical investigators and good clinical practices.
KEY SUCCESS FACTORS
1. Bachelor’s degree in healthcare, business, public health, or related field. Master’s degree preferred.
2. 5+ years of experience in clinical research leadership or related area at a healthcare, academic, not-for-profit, or government organization.
3. 1+ years of experience in a leadership role.
4. Knowledge of complex clinical services and research environment.
5. Research certification preferred, such as Association of Clinical Research Professional (ACRP) or Certified Clinical Research Professional (CCRP).
6. Knowledge of guidelines, standards, and regulatory requirements related to research clinical trials.
7. Knowledge of research systems including electronic health records.
BENEFITS
Our competitive benefits package includes the following
- Immediate eligibility for health and welfare benefits
- 401(k) savings plan with dollar-for-dollar match up to 5%
- Tuition Reimbursement
- PTO accrual beginning Day 1
Note: Benefits may vary based upon position type and/or level
QUALIFICATIONS
- EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification
- EXPERIENCE - 5 Years of Experience
As a health care system committed to improving the health of those we serve, we are asking our employees to model the same behaviours that we promote to our patients. As of January 1, 2012, Baylor Scott & White Health no longer hires individuals who use nicotine products. We are an equal opportunity employer committed to ensuring a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Source : Baylor Scott & White Health