As the world's largest staffing and recruitment agency, we are dedicated to helping you find the ideal role that offers growth and development opportunities within the life sciences sector. We are partnering with a innovative biopharma developing drugs to treat neurodegeneration.
The CRA will be responsible for monitoring oversight, co-monitoring, and site management work to ensure that the CRAs working under the CRO(s) and the sites conducting the studies on behalf of Company, follow all applicable regulations, guidelines, and sponsor requirements. The CRA will work closely with study teams, investigators, and research sites to ensure the successful execution of clinical trials from start up through close out.
Ideally, the candidate is based in the Greater Philly area but open to candidates elsewhere that can work on-site occasionally. This role has an estimated 40-50% travel to clinical trial sites.
location: Malvern, Pennsylvania
job type: Permanent
salary: $135,000 - 150,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
Site Management and Monitoring
- Perform site co-monitoring visits at various timepoints in the study (selection, initiation, monitoring and close-out visits) to ensure CRAs working for the CRO on behalf of Company are monitoring in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- May conduct independent monitoring visits across the life cycle of a trial as required.
- Assist with site feasibility efforts, investigator selection, and site initiation activities.
- Evaluate patient safety, data quality/integrity, and protocol compliance at study sites, including adherence to applicable regulations.
- Identify and resolve any issues related to the conduct of the study, data accuracy, or site performance.
- Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, data query generation and resolution, AEs, and protocol deviations.
- Ensure copies/originals (as required) of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding CRO CRA monitoring oversight, including monitoring visit findings, tracking monitoring visits according to the Clinical Monitoring Plan, and by submitting regular co-monitoring visit reports.
- Ensure timely reporting of safety data and AEs to the appropriate stakeholders.
- Provide training and support to CRO CRAs and site staff regarding study protocols, GCP and applicable regulations.
- Support development of project subject recruitment plan on a per site basis.
- Support sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
- Assist CRO CRAs and vendors to troubleshoot site issues.
qualifications:
- Bachelor's Degree and minimum of 5 years on-site monitoring experience Phase I-IV clinical trials.
- Experience in neurology clinical research monitoring or study coordination.
- Background in Alzheimer's Disease and/or Parkinson's Disease preferred.
- Experience with neurological assessment scales preferred (MDS-UPDRS, MMSE, ADAS-Cog, CDR, WAIS, etc.).
- Extensive knowledge of and skill in applying applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Strong communication skills (written and verbal) and strong organizational and problem-solving skills with the ability to anticipate and address issues before they become problems.
- Ability to interact professionally with investigators, site staff, vendors, and internal teams.
- Ability to work independently and within a team, with attention to detail and accuracy.
- Ability to adapt to change and thrive in a dynamic work environment with tight deadlines.
skills: CRF, GCP (Good Clinical Practice), COV (Close-Out Visit), RMV (Routine Monitoring Visit), SIV (Site Initiation Visit), TR (Trip Report), ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
