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location: Cambridge, Massachusetts
job type: Contract
salary: $28.00 - 33.69 per hour
work hours: 9 to 5
The in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the the Clinical Project Manager(s). The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager. The CRA performs work within established protocols under general supervision.
Study Start-Up Activities:
- Assists the study team(s) to deliver the clinical study within agreed timelines.
- Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors. (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.)
- Provides oversight of Clinical CRO Investigator background checks.
- Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary.
- Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.
- Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items.
- Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager.
- Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System.
- Assists and/or participates in planning and conduct of Investigator's Meetings as necessary.
Study Maintenance Activities:
- Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced.
- Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager.
- Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present.
- Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements.
Study Close Out Activities:
- Assists study team with preparation for audits/inspections
- Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager.
- Liaises with Transparency group to ensure Clintrials.gov and results are updated/distributed accordingly.
- Development tasks may be assigned to a CRA as appropriate upon discussions with manger:
- Assist in providing oversight of CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval.
- Maintains knowledge and act as team super user or subject matter expert for related systems and processes.
- Maintains up to date training record attending internal/external training(s) as necessary.
- Participates in inter-departmental workgroups to create or enhance processes.
- Bachelor's degree required
- 1-3 year's experience in similar/relevant field (eg.Sponsor, CRO, Clincal trial Vendor, Clincal Coordinator, etc.)
- Relevant experience in clinical research or related field
- Adequate Good Clinical Practice training
- General knowledge of regulatory requirements and guidelines governing clinical research
- Comfortable with technology and ability to learn new systems quickly
- Strong knowledge of MS Word, Excel, PowerPoint and Outlook
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines
- Must be able to professionally interact and communicate with visitors, vendors, and individuals at all levels of the organization
- Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands
- Ability to work successfully within a cross-functional team
- Understanding how their input and role coordinate more effective business practices for the company
- Ability to take ownership and manage tasks as well as communicate effectively
- Ability to lead others to drive deliverables forward
- Must be able to work in a fast paced environment
- Demonstrate ability to prioritize multiple competing tasks
- Ability to work with minimal supervision and complete tasks according to deadlines
- Internal Contacts: Clinical Program Support, Clinical Programs, Clinical Medicine, Clinical Operational Excellence, Biometrics & Programming, Clinical Information Management, Clinical External Partners, Clinical Scientific Writing, Clinical Supplies and Pharmacovigilance
- External Contacts : CRO, Clinical Investigators, and Consultants
- Available for up to 10% domestic and/or international travel
skills: CRF, Clinical research, COV (Close-Out Visit), PSV (Pre-Study Visit), RMV (Routine Monitoring Visit), SIV (Site Initiation Visit)
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.