Provides supervision and leadership to the clinical research program and supports high quality research, customer service excellence and fiscal responsibility. Serves as a direct link between the clinical research staff and research administration. The Clinical Research Manager will provide consistent leadership and oversight of the daily operations of the department to ensure competent and standardized staff practices, and coordinates strategies to enhance interdepartmental communication and collaboration. Ensures compliance with all regulatory requirements and standards of good clinical practice related to the conduct of clinical research.
(25%)* Plans, organizes and directs a comprehensive research program.
(25%)* Ensures compliance with all regulatory requirements and standards of good clinical practice related to the conduct of clinical research. Interprets, develops and implements practices of all systems and functions to ensure continuous compliance.
(20%)* Directs, organizes, and supervises direct reports on a daily basis; provides feedback and mentoring to ensure quality measures are achieved. Completes job performance reviews, processes payroll and coaches and disciplines staff as necessary.
(15%)* Collaborates with investigators to assess potential new projects for feasibility.
(10%)* Responsible for fiscal management, including the identification of opportunities to reduce department expenses; develops the department's annual budget.
OTHER DUTIES AND RESPONSIBILITIES:
Manages distribution of work for the department including: Develops plans to ensure that appropriate human resources are in place to ensure the optimal daily functioning of the department.
Provides a timely assignment of resources to pre-study tasks and staffing of research studies, and monitoring coordinator schedules and effort.
Monitors staff performance to ensure high quality, utilizing day-to-day observation, frequent feedback, intermittent quality assessments, and metrics.
Interviews, hires, and orients new hires to the department.
Collects, reviews, analyzes, and interprets data from various sources to determine opportunities for improvement.
Develops new policies, procedures, and workflow processes as needed.
Negotiates contracts and budgets with study sponsors, external research agencies and investigators to ensure financial viability of the program.
Ensures clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
Collaborates with the investigators and research nurses, develops strategies for enrollment.
Reviews and assists with the preparation of documents to be submitted to the Institutional Review Board (IRB) and/or sponsors.
Prepares and provides oversight of all audits, including sponsor and Governmental audits.
Develops department goals and objectives in collaboration with the Medical Director of Cardiovascular Research, the Cardiovascular Service Line Director, the Chief of Oncology Services and the Oncology Service Line Director.
Monitors and communicates to all audiences (including frontline staff, leadership and executives) on the action plans in the department.
Maintains awareness of Informatics Technology issues, communicates with Chief Information Officer as needed.
Performs other duties as assigned.
REQUIRED EDUCATION, EXPERIENCE, TRAINING AND SKILLS:
Master's degree required in business, health care administration, biology, life sciences, bioengineering or related field preferred.
Two (2) years of management experience including one (1) year in a healthcare organization.
Knowledge of, and experience with, computer based work processing, spreadsheet and database applications and/or practice management software.
Ability to exercise initiative, problem solving and decision-making and apply policies and principles to solve everyday problems and deal with a variety of situations.
Analytical skills needed to review complex sets of performance, financial and outcome data. Must be able to maintain strict confidentiality.
Previous management experience including coaching, leading and mentoring employees.
Leadership skills needed to effectively direct a group.
Excellent interpersonal skills needed to communicate successfully with individuals and groups and interact with people at all levels to communicate ideas and concepts in a clear and understandable manner.
MidMichigan Health is a technology driven organization and employees need to demonstrate competency in Microsoft® Windows.
An employee may be required to participate in further learning opportunities offered by MidMichigan Health.
Knowledge of nursing technique as normally acquired through the completion of an RN program and hold licensure in the State of Michigan.
Experience in research and clinical protocols and strategies.
PHYSICAL/MENTAL REQUIREMENTS AND TYPICAL WORKING CONDITIONS:
Exposure to stressful situations, including those involving public contact, as well as, trauma, grief and death.
Able to wear personal protective equipment that includes latex materials or appropriate substitute if required for your position.
Is able to move freely about facility with or without an assisted device and must be able to perform the functions of the job as outlined in the job description.
Overall vision and hearing is necessary with or without assisted device(s).
Frequently required to sit/stand/walk for long periods of time.
May require frequent postural changes such as stooping, kneeling or crouching.
Some exposure to blood borne pathogens and other potentially infectious material.
Must follow MidMichigan Health bloodborne pathogen and TB testing as required.
Ability to handle multiple tasks, get along with others, work independently, regular and predictable attendance and ability to stay awake.
Overall dexterity is required including handling, reaching, grasping, fingering and feeling.
May require repetition of these movements on a regular to frequent basis.
Physical Demand Level: Sedentary. Must be able to occasionally (0-33% of the workday) lift or carry 0-10 lbs.
Additional Salary Information: Salary is based on relevant years of experience and education level.
Internal Number: 4507
About MidMichigan Health
MidMichigan Health is a non-profit health system, headquartered in Midland, Michigan, affiliated with Michigan Medicine, the health care division of the University of Michigan. MidMichigan Health covers a 23-county region with medical centers in Midland, Alpena, Alma, Clare, Gladwin, Mt. Pleasant and West Branch. In addition to its Medical Centers, MidMichigan Health also offers both home health care and physician services, and has a strong commitment to medical education. MidMichigan Physicians Group provides urgent care and medical offices in more than 30 specialties and subspecialties including cardiology, hematology/oncology, orthopedics, vascular surgery, family medicine and more. The MidMichigan Health Foundation supports patients and families served by MidMichigan Health by raising funds for equipment, services and programs. Currently, MidMichigan has more than 7,800 employees, volunteers and physicians and provided $90 million in community benefits in fiscal year 2017.