Erin Miles Email and Phone Number

• Responsible for independent monitoring of multi-site assignments for Clinical Studies. Ensure adherence to Good Clinical Practices, investigator integrity and compliance with protocol and study procedures, at Investigator sites, in accordance with Novum SOP’s.• Review Regulatory Documents from Investigator Sites for completeness and accuracy. • Conduct site selection, initiation, close out and interim monitoring visits at assigned Investigator sites. • Review study site data to ensure compliance with the study protocol. • Verify CRF’s with source documentation. • Track SAE’s reporting at Investigator Sites.• Meet with Sponsor representatives as requested.• Review site’s regulatory binder to ensure that the master study files contain the most up to date information. • Review site’s drug accountability logs per patients and overall.• Monitor informed consents signed by study patients to ensure that the patients were consented properly and with the current revision. • Work with sites to resolve DCFs in a timely manner. • 70-80% travel required which may be irregular in nature and may include international travel.

• Order, interpret, and evaluate diagnostic tests to identify and assess patient's condition.• Direct or supervise less-skilled nursing or healthcare personnel or supervise a particular unit.• Consult and coordinate with healthcare team members to assess, plan, implement, or evaluate patient care plans.• Administer local, inhalation, intravenous, or other anesthetics.• Conduct specified laboratory tests.• Prescribe or recommend drugs, medical devices, or other forms of treatment, such as physical therapy, inhalation therapy, or related therapeutic procedures.• Maintain accurate, detailed reports and records.

• Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.• Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.• Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.• Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.• Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.• Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.• Communicate with laboratories or investigators regarding laboratory findings.• Order drugs or devices necessary for study completion.• Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.• Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.

• Confer with customer representatives, vendors, plant executives, or publisher to establish technical specifications and to determine subject material to be developed for publication.• Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology.• Maintain records and files of work and revisions.• Edit, standardize, or make changes to material prepared by other writers or establishment personnel.

• Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.• Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.• Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.• Communicate with laboratories or investigators regarding laboratory findings.• Order drugs or devices necessary for study completion.• Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.• Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.• Inform patients or caregivers about study aspects and outcomes to be expected.• Contact outside health care providers and communicate with subjects to obtain follow-up information.• Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.

• Supervise students' laboratory and clinical work.• Evaluate and grade students' class work, laboratory and clinic work, assignments, and papers.• Keep abreast of developments in the field by reading current literature, talking with colleagues, and participating in professional conferences.• Plan, evaluate, and revise curricula, course content, course materials, and methods of instruction.• Initiate, facilitate, and moderate classroom discussions.• Demonstrate patient care in clinical units of hospitals.• Assess clinical education needs and patient and client teaching needs using a variety of methods.• Maintain regularly scheduled office hours to advise and assist students.

• Advocate for clients or patients to resolve crises.• Collaborate with other professionals to evaluate patients' medical or physical condition and to assess client needs.• Refer patient, client, or family to community resources to assist in recovery from mental or physical illness and to provide access to services such as financial assistance, legal aid, housing, job placement or education.• Organize support groups or counsel family members to assist them in understanding, dealing with, and supporting the client or patient.• Modify treatment plans to comply with changes in clients' status.• Monitor, evaluate, and record client progress according to measurable goals described in treatment and care plan.• Supervise and direct other workers providing services to clients or patients.• Identify environmental impediments to client or patient progress through interviews and review of patient records.

• Monitor, record, and report symptoms or changes in patients' conditions.• Maintain accurate, detailed reports and records.• Record patients' medical information and vital signs.• Direct or supervise less-skilled nursing or healthcare personnel or supervise a particular unit.• Consult and coordinate with healthcare team members to assess, plan, implement, or evaluate patient care plans.• Prepare patients for and assist with examinations or treatments.• Prepare rooms, sterile instruments, equipment, or supplies and ensure that stock of supplies is maintained.• Direct or coordinate infection control programs, advising or consulting with specified personnel about necessary precautions.• Prescribe or recommend drugs, medical devices, or other forms of treatment, such as physical therapy, inhalation therapy, or related therapeutic procedures.• Engage in research activities related to nursing.

• Monitor, record, and report symptoms or changes in patients' conditions.• Maintain accurate, detailed reports and records.• Record patients' medical information and vital signs.• Order, interpret, and evaluate diagnostic tests to identify and assess patient's condition.• Direct or supervise less-skilled nursing or healthcare personnel or supervise a particular unit.• Consult and coordinate with healthcare team members to assess, plan, implement, or evaluate patient care plans.• Prepare patients for and assist with examinations or treatments.• Assess the needs of individuals, families, or communities, including assessment of individuals' home or work environments, to identify potential health or safety problems.• Conduct specified laboratory tests.• Direct or coordinate infection control programs, advising or consulting with specified personnel about necessary precautions.

• Administer first aid treatment or life support care to sick or injured persons in prehospital settings.• Perform emergency diagnostic and treatment procedures, such as stomach suction, airway management, or heart monitoring, during ambulance ride.• Immobilize patient for placement on stretcher and ambulance transport, using backboard or other spinal immobilization device.• Assess nature and extent of illness or injury to establish and prioritize medical procedures.• Communicate with dispatchers or treatment center personnel to provide information about situation, to arrange reception of victims, or to receive instructions for further treatment.• Observe, record, and report to physician the patient's condition or injury, the treatment provided, and reactions to drugs or treatment.• Operate equipment, such as electrocardiograms (EKGs), external defibrillators, or bag valve mask resuscitators, in advanced life support environments.• Attend training classes to maintain certification licensure, keep abreast of new developments in the field, or maintain existing knowledge.• Coordinate with treatment center personnel to obtain patients' vital statistics and medical history, to determine the circumstances of the emergency, and to administer emergency treatment.