Director - Clinical Research

Presbyterian Health Services   •  

Albuquerque, NM

Industry: Healthcare

  •  

5 - 7 years

Posted 76 days ago

This job is no longer available.

About Us

Presbyterian Healthcare Services is a locally owned, not-for-profit healthcare system of eight hospitals, a statewide health plan and a growing multi-specialty medical group. Founded in New Mexico in 1908, it is the state's largest private employer with approximately 11,000 employees.

Presbyterian's story is really the story of the remarkable people who have chosen to work here. Starting with Reverend Cooper who began our journey in 1908, the hard work of thousands of physicians, employees, board members, and other volunteers brought Presbyterian from a tiny tuberculosis sanatorium to a statewide healthcare system, serving more than 700,000 New Mexicans.

We are part of New Mexico's history - and committed to its future. That is why we will continueto work just as hard and care just as deeply to serve New Mexico for years to come.

Job Description

Education:
Essential:
* Master Degree

Other information:
* Masters Degree in a health science discipline, or business administration
* 5+ years in research administration or clinical research experience
* 5 years management experience at least 3 years of which are related to clinical research activities
* Clinical experience preferred - (RN, NP, PA)

Preferred Certification in any of the following: Certified Clinical Research Professional (CCRP); Certified Clinical Research Coordinator (CCRC); Certified Research Associate (CCRA); Certified Healthcare Research Compliance (CHRC); or Certified Healthcare Compliance (CHC)

Summary:
This position provides direct oversight for all clinical research activities at Presbyterian Healthcare Services. As the subject matter expert for clinical research, this position willoffer strategic leadership to the Presbyterian Clinical Lead Team (PCLT) Research subcommittee by ensuring: alignment of research activities with PHS strategic goals and initiatives; ongoing evaluation, development, monitoring and improvement of research processes for regulatory compliance, risk mitigation, patient / study participant safety and satisfaction; engagement and training of research staff; and facilitation of cross functional teams to attain objectives. This includes coordination and collaboration withdepartments participating in or impacted by clinical research as well as administrativesupport areas such as finance and revenue cycle.

Responsibilities:
* Represent the research program and research areas at the institutional level and with external collaborators.

* For all research activities conducted at PHS, ensure compliance with all applicable state and federal regulations, accrediting agency requirements and, institutional policies and procedures.Report any instances of non-compliance to PHS Compliance, Internal Audit and Legal departments as appropriate. Ensure implementation of corrective actions. Report all issues and outcomes to PCLT.

* Drive direction of research activities by evaluation and analysis of study portfolio to ensure that study participation meets defined objectives (e.g. patient population fit, alignment with provider / investigator interest and expertise, impact to operational areas, risk tolerance, resource availability, financial goals, etc.). Ensure appropriate operational, administrative and IRB approvals are received before studies are opened.

* Establish goals and metrics for measurements of success in research programs (e.g. number of studies opened; number of participants enrolled; financial targets; audit results; patient, member, and provider satisfaction, etc.). Measure and report metrics to PCLT, providing strategy anddirection to staff for realignment of activities to achieve goals.

* Evaluate ongoing needs for research site policy and procedures and collaborate with clinical or administrative departments impacted for development. (e.g. collaborate with PHS Pharmacy toensure adherence with New Mexico State Board of Pharmacy regulations regarding handling and management of investigational drugs,).


* Make determinations regarding complex elements of contracts/agreements in collaboration withFinance, Contracting and Legal

* Provide direct supervision of the PHS Institutional Review Board (IRB) Coordinators responsible for day to day operations of the Office of Human Research Protections

* Provide direct supervision, of staff in all PHS research departments. Ensure training and oversight with respect to subject screening; appropriate documentation; study participant consents; study monitoring and/or audits; and Adverse Event reporting. Address, correct andlead process improvement efforts.

* Identify and monitor training requirements for Principal Investigators and research staff and develop solutions to proactively ensure compliance with training requirements mandated by research regulatory bodies.

* Periodic internal review / audit / monitoring of study documents, including participant medical records, to verify compliance with study protocol and eligibility requirements, providing feedback and training to study staff.

Skills:
* In-depth understanding and knowledge of good clinical practices (GCP), regulatory environment, and business drivers related to research.
* Excellent management skills with high adaptability and strong collaborative management style.
* Leadership skills to align with overall organizational vision, purpose and strategy.
* Excellent communication skills to adapt to various target audiences, provide succinct, on-point presentations and recommendations to senior leadership and providers as well as detailed education to direct reports or collaborators as needed.
* Knowledge of process improvement tools and processes.

Benefits

Benefits are effective day-one (for .45 FTE and above) and include:

  • Competitive salaries

  • Full medical, dental and vision insurance

  • Flexible spending accounts (FSAs)

  • Free wellness programs

  • Paid time off (PTO)

  • Retirement plans, including matching employer contributions

  • Continuing education and career development opportunities

  • Life insurance and short/long term disability programs

About New Mexico

New Mexico's unique blend of Spanish, Mexican and Native American influences contribute to a culturally rich lifestyle. Add in Albuquerque's International Balloon Fiesta, Los Alamos' nuclear scientists, Roswell's visitors from outer space, and Santa Fe's artists, and you get an eclectic mix of people, places and experiences that make this state great.

Cities in New Mexico are continually ranked among the nation's best places to work and live by Forbes magazine, Kiplinger's Personal Finance, and other corporate and government relocation managers like Worldwide ERC.

New Mexico offers endless recreational opportunities to explore, and enjoy an active lifestyle. Venture off the beaten path, challenge your body in the elements, or open yourself up to the expansive sky. From hiking, golfing and biking to skiing, snowboarding and boating, it's all available among our beautiful wonders of the west.

JOB ID: 17623