The Associate CTM will assist the clinical operations project lead and the clinical team with day to day clinical study conduct activities per project team objectives. The ideal candidate will have keen attention to detail and the ability to both prioritize and handle multiple tasks effectively in a rapidly growing company environment. The Associate CTM will support the development programs for the osteoporosis or oncology therapeutic area. The Associate CTM will be expected to participate in the processing and performance of quality assurance checks of clinical trial data to ensure data integrity and consistency across clinical programs and in accordance with Radius standard operating procedures and Good Clinical Practices (GCP).
location: Waltham, Massachusetts
job type: Contract
salary: $65 - 75 per hour
work hours: 9 to 5
- Accountable for the oversight of clinical monitoring and site management activities outsourced to the CRO/Contract CRAs
- Conducts monitoring oversight visits to assess the performance of the monitoring team
- Reviews monitoring reports including quality checks and trend analysis across reports; participates in site related correction plan development and escalates issues to clinical operations project lead as appropriate
- Leads the day to day study operations support activities including tracking and creating overviews of study status, milestones and deliverables; performs quality check activities across components of the clinical study including progress of internal and external stakeholders activities (i.e. PV, Supply Chain, CRO, third party vendors, etc.)
- Navigates EDC systems and IRT systems and independently complete data reviews as needed to meet project objectives.
- Performs verification and quality control of essential regulatory documents and is well versed in the organization of a trial master file.
- Assists with the set-up of the clinical database (UAT testing).
- Assists with vendor management activities (i.e. selection, oversight, performance reports, etc.)
- Creates & maintains study specific tracking tools and project files as needed.
- Oversees management of internal investigational product supplies activities at the country (where applicable) and trial site level, keeping sites informed of drug lots/batches and expiration dates. Ability to review and perform drug accountability if required.
- Assist in the preparation of site and in-house Sponsor inspections.
- Maintains/develops a good level of scientific knowledge within the Project's therapeutic area.
- Effectively communicates with study team members and works closely to address challenges.
- Assists with NDA activities as needed.
- Helps to identify, create & establish study tools for department
- Consistently performs duties within established Standard Operating Procedures, and in accordance with Good Clinical Practices.
- Required Bachelor's degree, in a health science related field is preferred
- 5-7 years of clinical research experience at a CRO or Biotech/Pharmaceutical company, at least 2 years of on-site clinical trial monitoring or clinical research coordinator experience is preferred.
- Oncology or osteoporosis experience a plus
- Advanced understanding of study trial design, trial execution and operations (including creating study tools).
- Excellent computer skills (Microsoft Office Suite, Outlook) required.
- Excellent organizational & time management skills
- Willingness to work in a flexible environment
- Sound working knowledge of knowledge of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required.
- Global trial experience a plus.
- Some travel required (as needed basis; not continuous).
skills: Clinical research, GCP (Good Clinical Practice)
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.