Safety Monitor 3

Location
Rockville, Maryland
Salary
Competitive
Posted
Sep 12, 2023
Closes
Oct 12, 2023
Ref
2023-1678
Industry
Science
Hours
Full Time
Overview

Safety Monitor 3

US Remote

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee - from entry level through top executive - to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Safety Monitor is responsible for coordinating the safety aspects of projects in conjunction with the Medical Monitor and the project team.

We are looking to have someone to join the team in JANUARY 2024 .

Responsibilities

Key Accountabilities/Duties/Responsibilities

• Coordinates safety monitoring activities with Project Medical Monitor.

• Reviews safety events

o Provides first line evaluation of serious adverse events (SAEs).

o Communicates with site staff regarding reported AEs or SAEs to gather

additional information.

o Prepares a summary narrative for each reported SAE suitable for inclusion in DSMB reports,

regulatory submissions and final study reports.

o Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.

o Reviews adverse events for the study on a regular basis

• Communicates with sponsor, investigator site staff, pharmaceutical and other study

partners.

o Responds to site, sponsor, pharmaceutical partner requests for information regarding

safety in clinical trials.

o Participates in Data Safety Monitoring Board (DSMB) or other safety review

committee (SRC) meetings as necessary

o Reviews and contributes to DSMB/SRC reports regarding safety, reviews and

contributes to safety sections of annual report, and periodic safety reports

• Coordinates with project staff

o Participates in project team meetings

o Participate in the planning, preparation, and development of all safety-related

sections of protocols, study specific Manual of Operations (MOP), project

SOPs, and ancillary documents to ensure project compliance with corporate

SOPs

o Contribute to the development and implementation of the safety Case Report

Forms (CRF) and Safety Monitoring Plans (SMP).

o Maintains documentation required by corporate and project SOPs

o Participates in project process improvement and corporate quality assurance

activities through Internal Quality Audit Team (IQAT) processes, project SOP and

Compliance/Variance table development, participation in both internal and external audits,

as well as professional development activities.

• Performs MedDRA and WHO Drug coding, as applicable.

• Other corporate activities including annual SOP reviews, development, and teaching

EmmesU classes, participation in corporate safety meetings/activities; and other

corporate PV activities.

• Other duties as assigned.

Qualifications

Required Education and Experience

RN degree, PA degree or bachelor's degree in a scientific discipline with equivalent clinical

experience.

4-5 years clinical research, clinical direct patient care and/or Pharmacovigilance/Drug Safety; experience within a CRO is strongly preferred.

• Demonstrated experience with clinical trial data collection and safety monitoring with experience in safety monitoring/pharmacovigilance commensurate with job leveling chart.

• W orking knowledge of MedDRA and WHO Drug coding preferred

Required Skills/Abilities

• Demonstrated use of medical terminology and ability to extract information to create a case history.

• Excellent clinical judgment and ability to communicate complex clinical issues in a

scientifically sound and understandable way.

• Excellent oral and written communications skills.

• Ability to work as a team member and function on a cross-functional team.

Required Job Behaviors

Collaboration: Contributes outstanding teamwork in the achievement of group and

corporate goals.

Initiative: Exhibits resourcefulness and action in making independent sound decisions.

Results-Oriented: Performs beyond current job to meet critical deadlines and

deliverables.

Service-Oriented: Provides inspired service to internal/external clients that goes

beyond the expected.

Responsibility: Takes ownership of a situation and significantly improves processes

and/or service.

Emmes requires all US based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Unlimited Approved Leave


  • Tuition Reimbursement


  • 401k Retirement Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


CONNECT WITH US!

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.