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Manager - Clinical Research

3 months ago

Midlothian, United States Bon Secours Mercy Health Full time

At Bon Secours Mercy Health, we are dedicated to continually improving health care quality, safety and cost effectiveness. Our hospitals, care sites and clinicians are recognized for clinical and operational excellence.

With a legacy that spans over 150 years, Bon Secours is a network that is dedicated to providing excellent care through exceptional people. At every level, everyone on our teams have embraced the call to provide compassionate care. Here, you can work with others who share common values, and use your skills to help extend care to all of our communities.

**Job Description**

Job Title: Manager Clinical Research

Reports to: Director of Operations and Medical Director of Research

# Direct reports: 4+ (could be as high as 20)

**I. 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.

**II. 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 Researchs 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.

**III. Patient Population**

Demonstrates the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit.

Demonstrates knowledge of the principles of growth and development of the life span and possesses the ability to assess data reflective of the patient's status and interprets the appropriate information needed to identify each patient's requirements relative to his or her age, specific needs and to provide the care needed as described in departmental policies and procedures.

Adolescents (13-17 years)

Adults (18-64 years).

Geriatrics (65 years and older)

**IV. Employment Qualifications**

**Required Minimum Education:**

4 year/ Bachelors Degree

**Preferred Education:**

Graduate Degree (Masters)

**Specialty/Major:**

BSN, MSN, MBA, MS, MPH etc.

**Licensure/Certification Preferred:**

RN; CCRP, ACRP, 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.**

**V. Working Conditions**

Periods of high stress and fluctuating workloads may occur.

Long-distance or air travel as needed- not to exceed 10% travel.

General office environment.

May be exposed to limited hazardous substances or body fluids.*

May be exposed to human blood and other potentially infectious materials.*

May have periods of constant interruptions.

Required to car travel to off-site locations, occasionally in adverse weather conditions.

_* Individuals in this position are required to exercise universal precautions, use personal protective equipment and devices, and learn the policies concerning infection control._

**VI. Physical Requirements**

**Physical Demands**

Frequency

1-33%

34-66%

67-100%

Lifting/ Carrying (0-50 lbs.): 1 33%

Lifting/ Carrying (50-100 lbs.): 0%

Push/ Pull (0-50 lbs.): 0%

Push/ Pull (50-100 lbs.): 0%

Stoop, Kneel: 1 33%

Crawling: 0%

Climbing: 0%

Balance: 0%

Bending: 1 33%

**Work Position**

Sitting: 34 66%

Walking: 1 33%

Standing: 1 33%

**Notice of Employment At Will**

This document does not create an employment contract, and employment with Bon Secours Health System is "at will."

Nor is this document an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the essential and non-essential functions of the job at any time or require that other or different tasks be performed when circumstances change (i.e. emergencies, changes in personnel, workload, rush jobs or technical developments). Management will attempt to give reasonable notice prior to revising a job function or requiring performance outside of this description.

Bon Secours Mission, Values, Customer Orientation and Continuous Quality Improvement Focus

It is the responsibility of all employees to learn and utilize continuous quality improvement principles in their daily work.

Consistent with the Companys Code of Conduct, all employees are responsible for extending the mission and values of the Sisters of Bon Secours by understanding each customer, treating each patient, staff member, and community in a dignified manner with respect, kindness, and understanding and subscribing to the organization's commitment to quality and service.

**APPROVALS: DATE**

Department Director:

Administration:

Human Resources:

Many of our opportunities reward* your hard work with:

Comprehensive, affordable medical, dental and vision plans

Prescription drug coverage

Flexible spending accounts

Life insurance w/AD&D

Employer contributions to retirement savings plan when eligible

Paid time off

Educational Assistance

And much more

*Benefits offerings vary according to employment status

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 Employers, 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