Clinical Research Manager (RN) at Memorial Healthcare – Owosso, Michigan

JOB SUMMARY

Under general supervision, The Clinical Research Manager (CRM) is responsible for managing the overall direction, planning, execution and oversight of research projects. Project management includes strategic planning, budget and resource management, data collection and clinical operational activities. The CRM establishes methods to implement and support clinical research, ensures timely submission of contract deliverables and processing of clinical agreements. Strives for superior performance by consistently providing a product, or service to leadership, and staff that is recognized as ultimately contributing to the patient and family experience. Recognizes and demonstrates understanding of patient and family centered care.

PRIMARY JOB RESPONSIBILITIES

1. Analyze and develop study protocols to establish best clinical practice.
2. Review protocols for consistency, identifies forms for data collection and analysis and assures validation of data collection mechanisms.
3. Coordinates activities of cross-functional teams and oversees operational, data management, regulatory, monitoring, and protocol development processes associated with clinical trials. Work closely with other departments to ensure efficiency within the clinical trial.
4. Selects, trains, develops and evaluates study personnel to ensure efficient project operation.
5. Oversee protocol-monitoring components of projects including oversight of Clinical Research Coordinators and Assistants.
6. Review, approve and oversee study budgets, contracts, regulatory and administrative documents.
7. Designs and implements efficient work processes, schedules and checklists to ensure routine clinical trial and other project activities are performed in accordance with corporate, project-specific Standard Operating Procedures (SOPs) and applicable regulatory agencies.
8. Represents project at Sponsor, Investigator, Training or Safety Review meetings, and/or Pharmacy and Therapeutics meetings.
9. Performs data management, regulatory, protocol monitoring, protocol development and/or quality assurance duties, as appropriate.
10. Act as a liaison among the research staff, principal investigators, study participants, and research sponsors.
11. Certification for Good Clinical Practice (ICH/GCP) requirements, and Food and Drug Administration (FDA) regulations are required, as are certifications in the appropriate clinical research areas
12. The clinical research manager may also assist with recruitment of study participants and principal investigators.
13. Develop timelines and negotiate deliverables to ensure a timely, on-budget study.
14. Requirements:
    1. Participation in Leadership meetings.
    2. Participates in policy and procedure development.
    3. Responsible for ensuring The Joint Commission (TJC) and regulatory compliance.
    4. Participant in organization and leadership development programs.
    5. Responsible for annual employee performance evaluations.
    6. Conducts all written and formal disciplines with employees in coordination with Human Resources.
15. Demonstrates knowledge of and supports hospital mission, vision, value statements, standards, policies and procedures, operating instructions, confidentiality statements, corporate compliance plan, customer service standards, and the code of ethical behavior.

DEPARTMENTAL AND ADDITIONAL JOB RESPONSIBILITIES

1. Local and out-of-town travel may be required
2. Other job duties as assigned.

JOB SPECIFICATIONS

EDUCATION

1. Bachelor’s Degree required; at least 3 years of experience directly related to the Primary Job Responsibilities.
2. Completed degree (s) from an accredited institution that is above the minimum education requirement may be substituted for experience on a year for year basis
3. Current certification in Basic Life Support (BLS) required.

EXPERIENCE

1. Three to five years of clinical research experience.
2. Minimum two years’ experience conducting/coordinating Clinical Research Trials preferred.
3. Excellent organizational and communication skills, as well as leadership skills, good attention to detail, effective problem solving abilities, and excellent interpersonal skills are a must.
4. Ability to develop and deliver presentations.
5. Knowledge of accreditation and certification requirements and standards.
6. Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
7. Ability to observe, assess, and record symptoms, reactions, and progress.
8. Ability to maintain quality, safety, and/or infection control standards.
9. Skill in the use of personal computers and related software applications.
10. Knowledge of the principles and procedures of clinical research.
11. Records maintenance skills.
12. Skill in budget preparation and fiscal management.
13. Knowledge of human resources concepts, practices, policies, and procedures.
14. Knowledge of inventory management practices.
15. Skill in organizing resources and establishing priorities.
16. Knowledge of drugs and their indications, contraindications, dosing, side effects, and proper administration.
17. Knowledge of contracts and grants preparation and management.
18. Ability to design and implement systems necessary to collect, maintain, and analyze data.
19. Ability to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments.
20. Ability to make administrative and procedural decisions and judgments on sensitive, confidential issues.
21. Knowledge of federal, state and/or community funding sources and mechanisms.
22. Ability to recruit, evaluate, and instruct clinical research subjects and volunteers.
23. Ability to prepare and process laboratory samples using established protocols.
24. Knowledge of specimen collection and processing preferred.

ESSENTIAL PHYSICAL ABILITIES/MOTOR SKILLS

1. Able to travel independently throughout all Memorial Healthcare facilities.
2. Small motor skills required for operating modern computer, office, and telephone equipment as utilized by Memorial Healthcare (MHC).
3. Bending, lifting, standing, walking and sitting for long periods related to research task working with subjects

ESSENTIAL TECHNICAL ABILITIES

1. Proficiency using modern office, computer and telephone equipment as used by Memorial Healthcare.
2. Technical ability to utilize trial sponsored EDC (electronic data capture) systems, Central laboratory processing and other trial sponsor related activities.

ESSENTIAL MENTAL ABILITIES

1. Ability to adapt and maintain focus in fast paced, quickly changing or stressful situations.
2. Ability to read and interpret a variety of documents including, but not limited to policies, operating instructions, white papers, regulations, rules and laws.

ESSENTIAL SENSORY REQUIREMENTS

1. Able to see for the purpose of reading information received in formats including but not limited to paper, computer, reports, bulletins, updates, manuals.
2. Able to hear for work-related purposes.

INTERPERSONAL SKILLS

1. Ability to interact with co-workers, hospital staff, administration, patients, physicians, the public and all internal and external customers in a professional and effective, courteous and tactful manner, at all times, physically, verbally and in all written and electronic communication.
2. Required to remain calm when adversity is encountered.
3. Open, honest, and tactful communication skills.
4. Ability to work as a team member in all activities.
5. Positive, cooperative and motivated attitude.