The in-house Sr. Clinical Research Associate (Sr. CRA) is responsible for independently providing support to the Clinical Project Manager(s) for day to day clinical study activities. The Sr. CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussion with manager. The Sr. CRA performs work within established protocols under general supervision.
80% - Clinical Trial Support (May include but not limited to activities listed)
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.
- Assists with oversight of Clinical CRO activities regarding amendments to country and site specific informed consent documentation tracking, finalization and approval.
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.
10% - Development Tasks
Development tasks may be assigned to a Sr. CRA as appropriate upon discussion with manger:
- Provides clinical study start up expertise and ensures identified efficiencies within study start-up are implemented.
- Assists in providing oversight of site identification and selection.
- Provides oversight of Clinical CRO activities regarding Legal review/negotiation/execution of confidentiality and site agreements.
- Provides oversight of Clinical CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval.
- Ensures effective communication between Takeda and the Clinical CRO.
10% Departmental Tasks
- 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 work-groups to create or enhance processes.
Education and Experience Requirements
- Minimum of a Bachelor's degree required
- At least 3 year's experience in similar/relevant job (eg. Sponsor, CRO, or Clinical Study Vendor)
Other Job Requirements
- Available for up to 10% domestic and/or international travel
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.