Clinical Research Associate jobs in Westfield, MA

Overview:
We are seeking a skilled and dedicated Research Nurse to join our team. As a Research Nurse, you will play a crucial role in conducting clinical trials and supporting research activities. This position requires strong knowledge of clinical research, as well as proficiency in various laboratory techniques and data analysis tools. Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and close monitoring while the subjects are on study. Responsible for all data collection, source documentation and submission of adverse experience reports.

Duties and Responsibilities:

Duties include but are not limited to:

· Supports enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements.

· Ensures the protection of study patients by timely adherence to protocol requirements/compliance

· Attends monthly staff meetings and teleconferences.

· Attends weekly study status teleconference.

· Maintains patient confidentiality according to ethical and legal requirements.

· Adheres to appropriate Standard Operating Procedures

· Is familiar with the protocols on which the patients are enrolled

· Uses the protocol as the only tool to screen, treat, and follow patients

· Reviews the study design and inclusion/exclusion criteria with physician and patient.

· Complete and document screening/eligibility accurately

· Complete and document the informed consent process accurately and have all parties fully execute the document including HIPAA Authorization

· Complete the inclusion/exclusion form and standard enrollment form accurately

· Assess the patient and document findings at each clinic visit while on protocol

· Document all specific tools required by the protocol (i.e. oral medication forms, pill count diaries, quality of life questionnaires, neuro exams, vital signs sheets, times of PK draws, etc.)

· Screen every new patient or patient returning to office with scan results and document appropriately on the patient tracking logs

· Complete the study medication order form accurately and have the physician or nurse practitioner sign orders prior to treatment

· Ensure that all medications, including antiemetics, are approved by the registrar prior to initiating treatment or when changing medication regimens, such as crossover studies

· Accurately calculate and document the BSA, creatinine clearance, urine protein: creatinine ratio or any other conversions needed per protocol

· Document any interaction regarding the patient that occurs while the patient is enrolled on a protocol, including follow-up and survival (this includes home health intervention, pharmacies, study managers, physicians, and clinic colleagues)

· Ensure that follow-up appointments, scans, or any related procedures are scheduled correctly according to protocol requirements

· Inform, document and notify appropriate colleagues when patient comes off study

· Accurately complete all data and query requests and submit with source documentation within the timeframe specified by the study manager.

· Obtain completed and signed waivers prior to submitting forms to enrollment coordinator for investigator-initiated protocols

· Reconsent patients in a timely manner and document process appropriately

· Accurately completes initial SAE report and submits to the Safety Department within 24 hours of becoming aware of the event

· Accurately completes and submits follow-up SAE report to the Safety Department within the timeframe allotted by the Regulatory Department.

Skills:
- Strong knowledge of clinical research methodologies and protocols
- Proficiency in data analysis tools such as SAS or R
- Familiarity with laboratory techniques including cell culture, microscopy, PCR, etc.
- Understanding of animal physiology for preclinical studies
- Excellent communication skills to effectively interact with participants and the research team
- Attention to detail to ensure accurate data collection and documentation

Qualifications:
- Bachelor's degree in nursing or a related field (Master's degree preferred)
- Valid nursing license in the state of employment
- Prior experience in clinical research or a related field is highly desirable

We offer competitive compensation commensurate with experience. This is a full-time position with opportunities for career advancement within our organization.

If you are passionate about contributing to medical advancements through clinical research and possess the necessary skills and qualifications, we encourage you to apply. Please submit your resume and cover letter detailing your relevant experience and interest in this role.

Job Type: Full-time

Pay: $39.21 - $47.22 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Medical specialties:

• Oncology

Physical setting:

• Clinic
• Hospital

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Springfield, MA 01104: Relocate before starting work (Required)

Work Location: In person