Clinical Research Manager - Oncology - St. Francis Millennium Cancer Center

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Scheduled Weekly Hours:

40

Work Shift:

Days (United States of America)

Clinical Research Manager - Oncology - St. Francis Millennium Cancer Center

Summary of Primary Function/General Purpose of Position

The Manager - Clinical Research provides leadership within the local market conducting research and is responsible for the overall operations, execution, and oversight of the local research activities within the specific service line, or market, carrying out the research objectives of physicians, providers, and service line leaders. Responsible for the tactical operational delivery and execution of research studies, spanning from study start-up until closure of research. The Manager interacts routinely with the BSMH Office of Research in ensuring operational efficiencies, compliance, and standardization of functionalities supporting research studies. Engages with peers in similar roles across the ministry as a “community” through sharing of best practices, educational opportunities, and collaborating on shared research opportunities, where applicable. The Manager assists the BSMH Office of Research in the design, and development of the system-wide research program, and is responsible for the local implementation of a clinical research program. 

              

Essential Job Functions

• Responsible for the strategic development of the clinical research program and the day-to-day oversight of the conduct of research. Serves as lead point of contact person for sponsors, internal and external collaborators, and BSMH stakeholders supporting the research, i.e. pharmacy, imaging, supply chain. Lead person interacting with BSMH Office of Research.
• Creates and sustains a collaborative, healthy working environment marked by intradepartmental collaboration. In collaboration with the Administrative Director and Physician Leaders serves as the subject-matter-expert for feasibility and implementation of research studies, including but not limited to selection, negotiation, approval, launch and maintenance of clinical trials.
• This position serves as a resource for the department in aspects regarding current local and federal regulations, such as FDA, ICH/GCP, BSMH policies, and industry-sponsored research forecasting ensuring the compliant conduct of clinical research. Works in collaboration with the BSMH Office of Research’s Research Participation Protection Program (RP3).
• Responsible for department staffing, acuity assessment, and daily work productivity.  Manager is also responsible for HR related matters for the team. Interviews, hires, evaluates and councils assigned staff. Identifies and supports RN and staff professional development pathways, in collaboration with the BSMH Office of Research. Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
• Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards. Collaborates with leadership teams and the BSMH Office of Research to develop and implement the research budget that includes accrual targets and financial objectives.
• Responsible for development of recruitment strategies to increase enrollment. This includes marketing the research program to the hospital, local community, and referring physicians.
• Provides oversight for the development and management of research Standard Operating Procedures. Develops action plans designed to improve research operations and quality assurance functions including, but not limited to, research billing compliance.
• Responsible for compiling and reporting protocol activity, accrual data, and research financial information to administration and physicians and the BSMH Office of Research.
• Participates in Partner leadership activities, collaborates with the BSMH Office of Research to identify, implement and maintain quality metrics.
• Implements ministry-wide Clinical Trial Management System (CTMS), optimizes functionalities, and maintains oversight of the CTMS to provide user support, promote best practices, and ensure maximum use of the CTMS. This responsibility applies to other technological systems implemented ministry-wide for research efficiencies.
• Manages research portfolio through strategic relationships with industry, government sponsors, cooperatives, academia. Responsible for grant oversight; meeting individual grant goals and reporting to NCI grant administrators, as applicable.

This document is not an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. Employees may be required to perform other job related duties as required by their supervisor, subject to reasonable accommodation.

 

Employment Qualifications

Required Minimum Education:

• 4 year/ Bachelors Degree

Specialty/Major:

• BSN

Preferred Education:

• Graduate Degree (Masters)

Specialty/Major:

MBA, MS, MPH etc.

 

Licensure/Certification Required:

• RN

Licensure/Certification Preferred:

• OCN or SOCRA preferred

Minimum Qualifications

Minimum Years and Type of Experience:

• 5 years’ experience in an established clinical trial program with regulatory, contracting, procedural, and accrual responsibilities

Other Knowledge, Skills and Abilities Required:

• 2 years of supervisory experience

Other Knowledge, Skills and Abilities Preferred:

• Experience having conducted clinical research, experience using CTMS
• Combination of post-secondary education and experience in lieu of a nursing degree.

Bon Secours Mercy Health is an equal opportunity employer.

As a Bon Secours Mercy Health associate, you’re part of a Mission that matters. We support your well-being – personally and professionally. Our benefits are built to grow with you and meet your unique needs, every step of the way.

What we offer

• Competitive pay, incentives, referral bonuses and 403(b) with employer contributions (when eligible)
• Medical, dental, vision, prescription coverage, HSA/FSA options, life insurances, mental health resources and discounts
• Paid time off, parental and FMLA leave, shot- and long-term disability, backup care for children and elders
• Tuition assistance, professional development and continuing education support

Benefits may vary based on the market and employment status.

Department:

Clinical Research Greenville Oncology

It is our policy to abide by all Federal and State laws, as well as, the requirements of 41 CFR 60-1.4(a), 60-300.5(a) and 60-741.5(a). Accordingly, all applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, genetic information, or protected veteran status, and will not be discriminated against on the basis of disability. If you’d like to view a copy of the affirmative action plan or policy statement for Mercy Health– Youngstown, Ohio or Bon Secours – Franklin, Virginia; Petersburg, Virginia; and Emporia, Virginia, which are Affirmative Action and Equal Opportunity Employer, please email recruitment@mercy.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact The Talent Acquisition Team at recruitment@mercy.com.