The Emmes Group, a leader in clinical research, invites applications for the position of Clinical Research Associate (CRA) II. This remote role offers a unique opportunity to contribute to groundbreaking clinical trials and make a direct impact on patients’ lives.
About Emmes Group
For over 47 years, Emmes Group has been at the forefront of clinical research. Originally focused on U.S. government contracts, Emmes has expanded its expertise into public-private partnerships and commercial biopharma. With a strong foundation in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience, Emmes is committed to building a collaborative, innovative culture.
Job Responsibilities
As a Clinical Research Associate II, you will be responsible for monitoring clinical study sites to ensure adherence to protocols, regulations, and standard operating procedures (SOPs). Key responsibilities include:
- Conducting various monitoring visits such as qualification, initiation, routine, and closeout visits.
- Performing informed consent reviews, source data verification, adverse event reporting, and protocol compliance assessments.
- Documenting site visit observations and facilitating post-visit action item resolution.
- Providing training to site staff on protocols, GCP, and GDP.
- Assisting in the preparation of study-related materials and supporting audit preparations.
- Collaborating with internal and external colleagues to meet project objectives.
- Managing site recruitment strategies and patient recruitment action plans.
Qualifications
Applicants must meet the following criteria:
- Education: Bachelor’s degree (preferably in a scientific discipline) or equivalent work experience.
- Experience: At least 1-2 years of relevant monitoring experience (both on-site and remote).
Required Skills and Abilities
- Proficiency in MS Office Suite and excellent computer skills.
- Strong organizational and attention-to-detail abilities.
- Knowledge of clinical research operations, ICH guidelines, and country-specific regulations.
- Excellent interpersonal, communication, and problem-solving skills.
- Ability to work independently as a self-starter and collaboratively as a team player.
