Job Purpose: Responsible for the oversight and implementation of daily operations activities within the Research Department and maintaining a high performing team. Provide supervision and leadership to staff and administrative leadership to Research Committee. Ensure that the Clinical Research Department is in compliance with all internal and external policies and regulations, including but not limited to FDA, IRBs, SOPs, sponsor/CRO, ICH and GCP guidelines. Accomplishes department objectives by managing staff; planning and evaluating department activities.
Essential Functions: In order to perform this job successfully, an individual must be able to perform each essential function satisfactorily and regular attendance is required. The responsibilities listed below are representative of the primary essential functions required; additional duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Implement operational changes. Participate in and promote efforts to measure and track implementation of operational changes.
Provide recommendations to leadership to improve clinical care and company performance.
Oversight of all department operations regarding the contribution of research to align with company goals and strategies.
Job Specific Activities
Work closely with physicians, sponsors and all members of research team
Maintain the skills and expertise of a Research Coordinator including but not limited to: recruiting, screening, enrollments, follow up visits, assist procedures, SAE reporting and query resolution.
Responsible for consistent investigational product site accountability and reconciliation
Working knowledge of clinical trial management software.
Maintain membership and participation in clinical research organization(s).
Oversee and facilitate bi-monthly Research Committee meetings.
Maintain education and knowledge of FDA regulations and compliance. Assure staff training, orientation and familiarity with available resources, current regulations and processes.
Identify and request site resource needs including equipment, materials, EHR resources and staff.
Conduct periodic quality audits of clinical studies to ensure internal and external compliance.
Evaluate all potential protocols, identify any potential obstacles and make recommendations to Medical Director of Research and Research Committee regarding protocol feasibility and participation.
Negotiate positive study budgets and execute Clinical Trial Agreements (CTAs) in a timely manner.
Oversight and final approval of the study CTAs and study budgets.
Evaluate study assignments to ensure balanced work assignments and optimize recruitment.
Understand and recommend the best practices for processes performed in the department.
Responsible for department finances and internal budget, review revenue and expense budgets and performance and work directly with CPO and Medical Director of Research to make recommendations to improve financial performance.
Participate in the review of internal studies, including budget projections, protocol analysis and requesting IRB approvals where needed.
Ensure efficient use of company resources, maximum utilization of company facilities and safe and effective patient care. Identify barriers, bring forward issues and recommendations for resolution.
Develop, implement and enforce department standard operating procedures.
Develop and evaluate reasonable and measurable department variable pay goals.
Provide high quality clinical care by ensuring a well-functioning, collaborative team of staff.
Management of Resources:
Encourage two-way communication between self and staff; building rapport and trusting relationships with staff; engaging staff in process improvements.
Promote a Culture of Caring through leadership, interactions, and staff behavioral expectations.
Establish strategic goals by gathering pertinent business, financial, service, and operations information; identifying and evaluating trends and options; determining a course of action; defining objectives; evaluating outcomes.
Maintain staff by recruiting, selecting, orienting, and training employees; maintaining a safe work environment that embodies our Culture of Caring; developing opportunities for staff interested in professional growth.
Responsible for maintaining a high performing staff including providing adequate training, resources and staffing levels to support the efficient functioning of the department.
Achieve staff results by communicating job expectations; monitoring and appraising job results; coaching, counseling, and developing employees; developing, communicating, and evaluating policies, procedures, and productivity standards.
Maintains quality service by enforcing quality and patient care standards; analyzing and resolving quality and patient care problems; identifying trends; recommending system improvements.
Accomplish financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
Empower staff to maintain their timecards; providing support and making adjustments as needed; approve timecards within required timeframe.
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; implementing best practices; standardize and recommend process improvements, participating in professional societies.
Complete management responsibilities in accordance with company policy
Any and all other duties as assigned
Supervisory Responsibilities: Responsible for supervising the Clinical Research department
Qualification Requirements: The qualifications listed below are representative of the knowledge, skills, and/or abilities required to perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience Requirements: Bachelor’s degree is preferred. 2+ years of experience as a Clinical Research Coordinator required. Leadership experience preferred.
Certifications/Licenses: ARCP Clinical Research Coordinator Certification
Internal Number: CLINI02004
About MNGI Digestive Health
MNGI Digestive Health is a nationally recognized leader in gastroenterology diagnosis, quality and care.
Our Twin Cities-based physician practice specializes in the diagnosis and treatment of adult and pediatric digestive system disorders and our gastroenterologists have expertise in virtually all aspects of gastrointestinal (GI) care. Over the years, our doctors have been some of the first to introduce clinical advances in GI diagnostic and therapeutic techniques, making MNGI a leader in gastroenterology practice. As a frequent participant in national research studies - such blue light treatment of the stomach for eradication of H. pylori and trial medications to treat Hepatitis C - the practice provides opportunities for patients to participate in multi-center national and international clinical research trials.
Here at MNGI Digestive Health, we are caring people caring for people, where we foster a positive work environment that empowers our dedicated healthcare professionals to encourage and facilitate continued improvement in patient care practices. MNGI Digestive Health received proof that its employees and physicians love what they do - Their feedback has placed the company on the Star Tribune's list of Top Workplaces for five years in a row.