UNKNOWN

ADAPTED_NOW

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. Coordinates activities of cross-functional teams and oversees operational, data management, regulatory, monitoring, and protocol development processes associated with clinical trials.

<div>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<ol><li>Analyze and develop study protocols to establish best clinical practice.</li><li>Review protocols for consistency, identifies forms for data collection and analysis and assures validation of data collection mechanisms.</li><li>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.</li><li>Selects, trains, develops and evaluates study personnel to ensure efficient project operation.</li><li>Oversee protocol-monitoring components of projects including oversight of Clinical Research Coordinators and Assistants.</li><li>Review, approve and oversee study budgets, contracts, regulatory and administrative documents.</li><li>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.</li><li>Represents project at Sponsor, Investigator, Training or Safety Review meetings, and/or Pharmacy and Therapeutics meetings.</li><li>Performs data management, regulatory, protocol monitoring, protocol development and/or quality assurance duties, as appropriate. </li><li>Act as a liaison among the research staff, principal investigators, study participants, and research sponsors.</li><li>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</li><li>The clinical research manager may also assist with recruitment of study participants and principal investigators.</li><li>Develop timelines and negotiate deliverables to ensure a timely, on-budget study.</li><li>Requirements: <ol style="list-style-type:lower-alpha"><li>Participation in Leadership meetings.</li><li>Participates in policy and procedure development.</li><li>Responsible for ensuring The Joint Commission (TJC) and regulatory compliance.</li><li>Participant in organization and leadership development programs.</li><li> Responsible for annual employee performance evaluations.</li><li>Conducts all written and formal disciplines with employees in coordination with Human Resources.</li></ol></li><li style="margin-bottom:8px">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.</li></ol> DEPARTMENTAL AND ADDITIONAL JOB RESPONSIBILITIES<ol><li>Local and out-of-town travel may be required</li><li>Other job duties as assigned.  </li></ol> JOB SPECIFICATIONSEDUCATION<ol><li>Bachelor’s Degree required; at least 3 years of experience directly related to the Primary Job Responsibilities. </li><li>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</li><li>Current certification in Basic Life Support (BLS) required.</li></ol>    EXPERIENCE <ol><li>Three to five years of clinical research experience.</li><li>Minimum two years’ experience conducting/coordinating Clinical Research Trials preferred.</li><li>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.</li><li>Ability to develop and deliver presentations.</li><li>Knowledge of accreditation and certification requirements and standards.</li><li>Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.</li><li>Ability to observe, assess, and record symptoms, reactions, and progress.</li><li>Ability to maintain quality, safety, and/or infection control standards.</li><li>Skill in the use of personal computers and related software applications.</li><li>Knowledge of the principles and procedures of clinical research.</li><li>Records maintenance skills.</li><li>Skill in budget preparation and fiscal management.</li><li>Knowledge of human resources concepts, practices, policies, and procedures.</li><li>Knowledge of inventory management practices.</li><li>Skill in organizing resources and establishing priorities.</li><li>Knowledge of drugs and their indications, contraindications, dosing, side effects, and proper administration.</li><li>Knowledge of contracts and grants preparation and management.</li><li>Ability to design and implement systems necessary to collect, maintain, and analyze data.</li><li>Ability to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments.</li><li>Ability to make administrative and procedural decisions and judgments on sensitive, confidential issues.</li><li>Knowledge of federal, state and/or community funding sources and mechanisms.</li><li>Ability to recruit, evaluate, and instruct clinical research subjects and volunteers.</li><li>Ability to prepare and process laboratory samples using established protocols.</li><li>Knowledge of specimen collection and processing preferred.</li></ol> ESSENTIAL PHYSICAL ABILITIES/MOTOR SKILLS<ol><li>Able to travel independently throughout all Memorial Healthcare facilities.</li><li>Small motor skills required for operating modern computer, office, and telephone equipment as utilized by Memorial Healthcare (MHC).</li><li>Bending, lifting, standing, walking and sitting for long periods related to research task working with subjects</li></ol> ESSENTIAL TECHNICAL ABILITIES<ol><li>Proficiency using modern office, computer and telephone equipmentas used by Memorial Healthcare.</li><li>Technical ability to utilize trial sponsored EDC (electronic data capture) systems, Central laboratory processing and other trial sponsor related activities.</li></ol> ESSENTIAL MENTAL ABILITIES<ol><li>Ability to adapt and maintain focus in fast paced, quickly changing or stressful situations.</li><li>Ability to read and interpret a variety of documents including, but not limited to policies, operating instructions, white papers, regulations, rules and laws.</li></ol> ESSENTIAL SENSORY REQUIREMENTS<ol><li>Able to see for the purpose of reading information received in formats including but not limited to paper, computer, reports, bulletins, updates, manuals.</li><li>Able to hear for work-related purposes.</li></ol> INTERPERSONAL SKILLS<ol><li>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. </li><li>Required to remain calm when adversity is encountered.</li><li>Open, honest, and tactful communication skills.</li><li>Ability to work as a team member in all activities.</li><li style="margin-bottom:8px">Positive, cooperative and motivated attitude.</li></ol></div>

Memorial Healthcare

Clinical Research Manager

OTHER

FEED

The Clinical Research Nurse works under the guidance and supervision of the Principal Investigator, ensures the integrity and quality of clinical trials are maintained and conducted with federal, state, and local regulations, IRB board approvals, and MyMichigan Health policies and procedures. Provide in service education to the clinical staff of the hospitals (pharmacy, nursing, etc.) related to investigational drugs, devices, or procedures, including physiological effects, drug interactions, side effects, nursing care considerations, etc.

Summary:
Clinical Research Nursing is the specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity of the research protocol (ANA, 2016). The Clinical Research Nurse is responsible for human subject protection, care coordination and continuity, contribution to clinical science, clinical practice and study management. (IACRN, 2012). MyMichigan Clinical Research Nurses work within a dedicated Research Department as a part of the health system focused primarily on clinical trials in multiple specialty areas. Clinical trials may include pharmaceutical and device trials and other research projects directly related to patient treatment or care. The Clinical Research Nurse works under the guidance and supervision of the Principal Investigator, ensures the integrity and quality of clinical trials are maintained and conducted with federal, state, and local regulations, IRB board approvals, and MyMichigan Health policies and procedures.

Responsibilities:
(50%)* – Providing Direct Patient Care to Research Study Participants - Ensure compliance with each study’s protocol by providing through review and documentation at each study visit - Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements - Performs medical tests, including but not limited to, vital signs, lab draws and processing, and electrocardiograms - Administers investigational medication and performs patient assessments during clinic visits to determine presence of side effects; notifies Principal Investigator of findings/issues - Provides patient education and medical information to study participants to ensure understanding of proper medication dosage, administration, and disease treatment - Documents medical data in patient chart to capture protocol requirements (40%)* As a study coordinator, ensures assigned studies are conducted inaccordance with the Food and Drug Administration (FDA), Office of Research Protections (OHRP ), and Good Clinical Practice (GCP)guidelines - Ensure site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities - Develops accurate source materials to ensure compliance from all site staff - Provides accurate and timely data collection, documentation, entry, and reporting in both sponsors, Clinical Research leadership, and overseeing IRB, as indicated - Ensures appropriate training and credentialing for assigned protocols and associated staff - Supports the regulatory staff in the maintenance of regulatory documents - Communicates and collaborates specific study requirements to there search team, including internal and external parties, sponsors, monitors, PI, and study participants - Ensures compliance with research protocols through participation in ongoing quality control audits, including maintaining ongoing investigational drug accountability (10%)* – Complete required professional development and compliance training activities required by MyMichigan Health and as needed for the position. - Maintain Good Clinical Practice, IATA, and other training as required - Complete Annual Compliance Modules for position - Participate as a part of the research team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance - Occasional travel to attend sponsor study training meetings - On-call for weekends/evenings – rotated among all study coordinators – based on FTE allocation OTHER DUTIES AND RESPONSIBILITIES:Demonstrate excellent customer service. Always promotes subject safety. Contribute to the MyMichigan Health organization targets for patient satisfaction and net operating margin. Follow ALCOA principles for research documentation. Establish effective working relationships with participants, families, physicians, physician office staff, hospital staff, pharmaceutical company representatives, and research related visitors. Acts as liaison between all involved clinical areas and staff of the protocol requirements. Work collaboratively with investigators, sub investigators, referring physicians, other clinical research nurses, and hospital staff. Provides education for patients and families regarding the protocol, including the disease process, plan of care, symptom awareness, and the need to report adverse events. Provide in service education to the clinical staff of the hospitals (pharmacy, nursing, etc.) related to investigational drugs, devices, or procedures, including physiological effects, drug interactions, side effects, nursing care considerations, etc. Communicate serious adverse events to all appropriate sources. Accountable to the Manager of Cardiovascular Research. Represent MyMichigan Health as a professional, high-quality clinical site. Prepares, coordinates, and participates in on-site monitor visits. Analyzes protocol and assists in the creation of source documents. Coordinates activities related to billing, notification of appropriate departments, lab orders, etc. Understand and contribute to the functional unit plan goals and objectives that align with the organization's strategic plan. Follow patients and complete post-hospital follow ups, including clinical assessments. Performs blood draws and basic lab tests as required by the protocol. Coordinates and provides patient care and follow up to research patients as indicated per protocol and remains available 24 hours daily when on call. Educate study participants about their rights as research subjects, answer questions, and refer these to the primary investigator. Ascertain the adequacy of the document and obtain informed consent following the federal regulations before beginning study related procedures. Provides a copy of signed informed consent to the participant. Serve as a resource (along with the PI) for questions or concerns of the participant. Maintain OSHA and Universal Precautions and associated training. Keep participant's welfare uppermost in mind regarding emergencies, study procedures, termination of the study, etc. Provides participants with research-related materials. Reviews and has knowledge of Clinical Research policies and procedures. Complete and maintain source documents. Establishes procedures for randomization, blinding, and data collection. Resolve all sponsor queries regarding participant information. Per standard operating procedures, document follow up with participants about ongoing adverse events after study completion. Maintains, closes, and archives study documents according to standard operating procedure. 

Certifications and Licensures:
ACLS - Advanced Cardiac Life Support Preferred  BLS - Basic Life Support Required      Equivalent Experience - Within 1 month of hire or transfer RN - Registered Nurse Required      Equivalent Experience - BSN is preferred.

Required Education:
Education: Associates Degree Comments: Bachelor's degree in nursing preferred.

Other Information:
EXPERIENCE, TRAINING AND SKILLS:- Valid RN license - Two years of recent clinical nursing experience in a hospital, clinic, or similar health care setting - Knowledge of medical terminology, drug calculation skills, clinical medicine, clinical trials, and GCP concepts - Knowledge of federal, state and local regulations, including HIPAA policies and procedures - Detail oriented and meticulous in all aspects of work - Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative - Must have a professional demeanor, strong communication skills with patients and physicians and co-workers - Ability to work independently and as a part of a team - Strong interpersonal, customer service, and multi-tasking skills are critical - Must be proficient in Microsoft Office Word and EXCEL, electronic health systems and databases used in the research environment, or have the willingness to learn and demonstrate proficiency - Ability to work well under pressure, multi-task, and manage deadlines 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. Can 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 are 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 MyMichigan 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: Medium. Must be able to occasionally (0?33% of the workday) lift or carry 21?50 lbs., frequently 34?66% of the workday 20 lbs. and or Walk/Stand/Push/Pull of Arm/Leg controls and constantly (67?100% or the workday) 10 lbs.

Other Comments:

MyMichigan Health

Clinical Research Nurse RN

Advanced Cardiac Life Support (ACLS)

Adverse Events

Basic Life Support (BLS)

Biotech and Pharmaceutical

Cardiovascular

Clinical Assessment

Clinical Data Collection

Clinical Medicine

Clinical Nursing

Clinical Research

Clinical Training

Clinical Trial

Communication Skills

Customer Support/Service

Detail Oriented

Disease

Disease Treatment

Documentation

Drug Interactions

Drug Terminology

Electrocardiogram

Establish Priorities

FDA (Food and Drug Administration)

Federal Laws and Regulations

Follow Through

GCP (Good Clinical Practices)

HIPAA (Health Insurance Portability and Accountability Act)

Healthcare

Healthcare Quality

Hospital

IRB/IEC (Institutional Review Board/Independent Ethics Committee)

Identify Issues

Interpersonal Skills

Laboratory Testing

Leadership

Lift/Move 50 Pounds

Maintain Compliance

Medical Office

Medical Records

Medical Terminology

Medical Tests

Medication Administration

Microsoft Excel

Microsoft Office

Microsoft Word

Multitasking

Nursing

OSHA

On Call

Organizational Skills

Pathogens

Patient Assessment

Patient Care

Patient Charts

Patient Education

Patient Follow-up

Pharmacy

Phlebotomy

Problem Solving Skills

Quality Control

Quality Management

Registered Nurse (RN)

Regulations

Regulatory Requirements

Research Nursing

Research Protocols

Side Effects

Standard Operating Procedures (SOP)

State Laws and Regulations

Strategic Planning

Testing

Time Management

Treatment Plan

Willing to Travel

[AW]-iCims

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Clinical Research ManagerMemorial Healthcare

Clinical Research Nurse RNMyMichigan Health

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