Skip to main content

This job has expired

Central Safety Desk / Clinical Research Manager

Employer
Research Triangle Institute
Location
Durham, NC
Closing date
Oct 8, 2021

View more

Sector
Pharmaceutical, Pharmacovigilance
Organization Type
Corporate
CRNC is currently seeking an experienced Clinical Research Manager to oversee development and implementation of research projects and provide pharmacovigilance services for research studies (e.g., drug, device, surgical, and behavioral.) The position can be based in-office within Research Triangle Park, NC or telework.
Please include a cover letter as the first page of your resume or attach as a separate document to your application.

Essential Duties:

Central Safety Desk
• Review and triage incoming serious adverse events from a variety of clinical research studies (i.e., all phases of research in a variety of therapeutic areas including study participants ranging from newborn to geriatric.)
• Assess clinical site designations of seriousness, expectedness, and relatedness of adverse events in accordance with study criteria and applicable regulations and report those adverse events to the sponsor, data safety monitoring board, medical safety monitor, and FDA as required by the specific study.
• Actively follow-up with site study staff (e.g., data managers, research nurses, and physicians) and or independent medical monitor(s) for information essential to case evaluation and resolution.
• Collaborate with teams in writing pharmacovigilance portions of protocols, manual of procedures, and safety management plans.
• Participate in on-site and remote monitoring with a focus on adverse event and serious adverse event reporting.
• Perform coding of adverse events and serious adverse events as needed using the Medical Dictionary for Regulatory Activities (medDRA.)

Clinical Research Manager
• Work on and oversee staff who work on complex protocols, such as IND and IDE studies and multi-site protocols.
• Prepare and distribute study documents including data collection forms, manuals of operations and technical memos to research sites from study start up to close out.
• Prepare and review IRB materials for the RTI IRB, central IRB and clinical research sites.
• Prepare training materials; participate in and/or lead trainings for clinical site staff.
• Assist study sponsor in assuring that the research site personnel are conducting the study according to the clinical protocol, "Good Clinical Practices," and regulatory requirements.
• As part of a team, manage project budgets and client deliverables.
• As part of a team, establish subcontracts for study services (e.g., drug procurement)

Qualifications:

• Bachelor's degree in health-related field and 8 years' related experience; Master's degree and 6 years' related experience; Postdoctoral degree and 1 year related experience; or equivalent combination of education and experience.
• Excellent oral and written communication skills (cover letter required)
• Ability to work successfully on multidisciplinary teams
• Ability to manage multiple projects and timelines simultaneously
• Experience with clinical site management, regulatory submissions, and data management systems (e.g., iMedidata, REDCap, and Safety Software)
• To qualify, applicants must be legally authorized to work in the Unites States and should not require now, or in the future, sponsorship for employment visa status

Desired Qualifications
• RN, NP, PA, or MD with research and pharmacovigilance experience preferred
• CCRP (or equivalent) certification a plus
• Staff and project management experience

The anticipated pay range for this role is between $100,000-$120,000. A geographic differential may also be applied to some work locations within the United States.

RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert