Clinical research associate - rare disease
Us remote worker
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 innovationWe believe in the power of truth, so much so that we named our company emmes, which means truthThrough 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 curiosityWe 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 clinical research associate will provide expert advice, guidance and general supervision to clinical monitoring team activities for designated rare disease projects and will monitor specified sites to ensure quality and integrity of data, compliance with standard operating procedures (sops), clinical monitoring plan, ich gcp, regulatory requirements, ensuring study completion on time and within budget.
Responsibilities
Oversees site visits to determine protocol and regulatory compliance and prepares required documentation
Primary point of contact for the company in the global medical research community and develops collaborative relationships with investigative sites and client company personnel
Leads the execution of contracts and the progress of clinical projects
Ensures data entry by investigational sites is accurate and entered in a timely manner
Responsible for working with cra managers to ensure quality, cost effectiveness, and timeliness of clinical trials
Liaises with other departments to revise/create and implement monitoring documents (monitoring checklists, templates, etc.)
Ensures that the professional activities of the department meet federal regulations (title 21 cfr) and fda guidelines, or corresponding country regulatory requirements
Coordinates investigator meetings, interacts with investigators, oversees project order changes, updates study guidelines, and completes quality control reports
May track clinical trial budgets, investigator payments, and coordination of studies
Mentors junior level clinical research associates
Experience
Bachelor’s degree in a scientific discipline or equivalent experience; combination of training and experience will be taken under consideration
Expertise monitoring rare disease trials required
Ability to travel domestically and internationally up to 75%
Minimum of 7 years of clinical research/monitoring experience
Strong understanding of regulatory obligations for a clinical research associate and relevant ich guidelines
Successful completion of acrp ccra or equivalent certification within one year of hire/transfer date
Skilled in prioritization, problem-solving, organization, critical thinking, decision-making, time management and planning activities
Self-motivated and high attention detail required
Ability to collaborate with internal and external colleagues and work well in team-oriented setting
Excellent oral and written communication; exceptional interpersonal skills
Ability to work remotely with a high degree of independence
Skilled in data management/computer proficient in microsoft office
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.
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 programWe offer a competitive benefits package focused on the health and needs of our growing workforce, including:
Unlimited approved leave
Tuition reimbursement
401k & profit sharing plan
Work from home anywhere in the us
Maternal/paternal leave
Casual dress code & work environment
Connect with us!
The emmes company, llc is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practicesAll 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.
