CLINICAL RESEARCH NURSE COVER LETTER TEMPLATE

• Responsible for the implementation, management, and administration of clinical trial protocols in the Neely Center for Clinical Cancer Research.
• Interfaces with federal and corporate sponsors, inpatient and outpatient facilities, departments and personnel to ensure a collaborative environment and high quality outcomes. 
• Implements clinical protocol management via study requirements within the Neely Center for Clinical Cancer Research, in collaboration with the Principal Investigator
• Safeguards the rights and wellbeing of the study participant
• Provides general operational support and administrative duties related to clinical activities for the research study. 
• Coordinates and delivers patient care and oversees and trains support personnel. 
• Reports to the Director, Clinical Research for the Neely Center for Clinical Caner Research.
• Screening of all new Research Subjects for actively enrolling clinical trials within different departments.

Skills: Clinical Trial Management, Stakeholder Collaboration, Protocol Implementation, Patient Safety Advocacy, Operational Support, Patient Care Coordination, Staff Training, Subject Screening

• Be responsible for performing scheduled events according to the study protocol.
• Work directly with study managers to successfully ensure a successful trial.
• Work with participants in the research process, doing vital sign checks, ECGs, blood draws and telemetry monitoring.
• Providing direct patient care involving diagnosis, administration of medications, and performance of tests under the direction of the principal investigator or supervising physician
• Providing health practices information and education to patients regarding medications, diseases, diet, exercise, and any special procedures
• Acting as a liaison for patient/physician telephone calls
• Assisting patients by providing appropriate referrals to physicians, clinics, or agencies
• Be able to evaluate if volunteers match all specificities of the clinical research.
• Represent the volunteers in a first contact/ experience with clinical research. 
• Communication skills are important

Skills: Event Coordination, Trial Management, Clinical Procedures, Patient Care, Health Education, Patient Liaison, Referral Assistance, Volunteer Screening

• Act as a key member of the clinical research team and ensure clinical trials are carried out according to their individual approved protocols.
• Administering study drug, collecting safety blood and conducting other clinical activities
• Combine strong clinical skills with a compassionate, engaging personality and a dedication to ensuring exceptional patient outcomes.
• Pre-and post-trial examinations, performing venepuncture, ECGs, observations and handling and processing of blood and urine samples.
• Some studies also require cannulation and IV infusion.
• Ensure the accurate reporting of adverse events (AEs) and be fully acquainted with procedures for reporting serious adverse events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) according to protocol.
• Select exams/collect data to validate the volunteers based on medical aspects.
• Interview face to face with volunteers
• Be able to evaluate if volunteers match all specificities of the clinical research.
• Represent the volunteers in a first contact/ experience with clinical research. 

Skills: Clinical Trial Oversight, Drug Administration, Patient Engagement, Clinical Procedures, Adverse Event Reporting, Data Collection, Volunteer Assessment, Patient Representation

• Working with providers to recruit, onboard and train home nurses.
• Developing and managing the team
• Oversee the service is running efficiently and that nurses attend visits, drugs and equipment are where they need to be.
• Service/financial reporting to the Director of Home Health
• Responsible for the running of multiple projects
• Working closely with clients to ensure the service is meeting needs.
• Work alongside a team of strong medical professionals. 
• Culture emphasizes the impact each employee can make on the lives of patients as they inspire innovation and empower better care.
• Form the link between researchers, pharmaceutical industry and study patients
• Organize and coordinate all study visits with patients according to established protocols
• Responsible for the Registration and follow-up of parameters and side effects as defined in the study protocol
• Familiar with blood sampling, processing blood and sending blood samples
• Work closely with lab, medical imaging, pathology and other services involved in clinical studies
• Responsible for the collection and the accurate processing of the data for input into the central database

Skills: Team Management, Service Coordination, Financial Reporting, Project Oversight, Client Relations, Collaborative Healthcare, Research Coordination, Data Management

• Participating actively in clinical meetings, rounds, and departmental meetings
• Preparing materials for submission to the IRB and participating in protocol development by drafting study protocols and/or reviewing potential protocols to evaluate their effect on standard nursing procedures
• Acting as a protocol resource for other research team members
• Preparing financial records including quarterly reports, budget, and subject-related expense
• Preparing for and completing close out procedures for terminated studies, ensuring all FDA, sponsor, and University regulations have been followed
• Collecting scientific samples and detailed, accurate data
• Arranging follow up medical care to insure ongoing monitoring of patients in research protocols Reporting adverse events to principal investigator and/or sponsor in a timely manner
• Reviewing medical records, reviewing clinical and laboratory evaluations
• Maintaining appropriate source documentation and appropriately and accurately completing patient charts and/or case reports
• Evaluating and enrolling patients in clinical research studies, obtaining patients’ informed-consent

Skills: Clinical Coordination, IRB Submissions, Protocol Development, Financial Management, Regulatory Compliance, Data Collection, Patient Follow-Up, Study Enrollment

• Clinical research experience, with background in a patient-facing role.
• Proven experience with research as well as knowledge of best practices for HIPAA, consent, GCP, FDA, SOP, OHRP, safety monitoring, and others.
• Must be able to display excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and other parties.
• EDC or medical record system experience a plus.
• Experience in Clinical Research as a bonus
• Ability to work independently but also enjoy teamwork environment
• Collaborative mindset and team spirit within a multidisciplinary team for the success of the project
• Fluency in English mandatory (written and spoken)

Qualifications: BS in Nursing with 4 years of Experience

• Strong team management experience.
• Experience in working with and managing vendors/providers.
• Cold supply chain management experience.
• Able to run multiple projects in multiple countries.
• Able to work collaboratively with other departments.
• Experience in data collection and handling information accurately
• Work in a structured way and are good at organizing
• Good knowledge of the Dutch, English, and preferably also French language
• Excellent interpersonal skills and the ability to prioritize and effectively communicate verbally and in writing.
• Coordinates multiple tasks and work independently and productively in a fast paced, deadline-oriented environment.

Qualifications: BS in Biochemistry with 3 years of Experience

• Work experience in clinical research trials as data collector, research nurse, or clinical coordinator.
• State of Connecticut licensure as a Registered Nurse (RN).
• Quality conscious with high degree of ethics and integrity carrying out duties in accordance with laws, regulatory standards, and with company policies and procedures.
• Current certification in Basic Life Support (BLS) required.
• Current certification in Advanced Cardiac Life Support (ACLS) required.
• Understanding and comprehension of scientific writing.
• Excellent verbal and written communication skills.
• Experience and understanding of effective electronic and distance communication methods (i.e. Email, Video Conferencing, IM).
• Proficiency in Microsoft (MS) Office and the ability to learn different software programs.
• Required availability to work beyond normal work hours 

Qualifications: BS in Biology with 5 years of Experience

• A strong working knowledge of computer software including Windows, Word, Excel, and Outlook
• Attention to detail and ability to follow and interpret approved clinical protocols is required.
• A strong working knowledge of GCP, ICH, CFR, and HIPAA laws and regulations 
• ECG, phlebotomy skills, and other technical skills related to the completion of a study visit as required by the protocol.
• Knowledge of Springfield Clinic policies and procedures.
• Ability to demonstrate good organizational skills, excellent oral & written communication skills
• Excellent interpersonal skills in working effectively with Co-workers, Managers, Directors, Administration, Providers, Staff, Sponsors and Patients.
• Ability to recognize, evaluate and solve problems.
• Ability to manage projects in a team environment.
• Ability to function and perform daily work independently, perform duties and tasks assigned and follow through to completion.

Qualifications: BS in Pharmacology with 7 years of Experience

• Must possess manual dexterity to handle equipment and appliances.
• Must possess good physical health.
• Must have the ability to control emotions and maintain composure under stress, using tact and good judgment.
• Must be available for shift or extended hours, as necessary, for research contingencies 
• Must be able to stand and walk for long periods and capable of stooping, bending, and lifting.
• Must be able to perform computer data input and retrieval.
• Registered Nursing qualifications are essential, preferably with experience in Respiratory or research nursing.
• Competence in the use of computers is required.
• Excellent communication skills with ability to relate to patients and staff.

Qualifications: BS in Biomedical Engineering with 2 years of Experience