Job Description
Job Description
Job Title : Clinical Trial Associate
Location : Metro Boston preferred, hybrid working model
Location : Waltham, MA
Remote Flexibility : 2-3 days / week on-site
Contract Term : 6 months to start; could extend or go perm
Experience required :
- Preference is experience at CRO or small biotech for at least 1-2 years with exposure to clinical sites including site startup and IRBs
- If no experience in CRO, then site experience as a study coordinator
- Larger biotech / pharma is okay if they've engaged directly with clinical sites
- Looking for someone that can work on RFI's out for vendors, phase 1 units, setting up trackers / tools, working with vendors, etc
- Okay with people that have been study coordinators that are hungry and looking to transition into industry
Position Overview : The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies. The CTA will support the Clinical Trial Managers in day-to-day activities including engaging vendors, starting up and managing clinical trials. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment.
Key Responsibilities :
Organize / maintain tracking systems and set up tools to support the conduct of a clinical study from start-up to close-outAssist with the development and review of clinical documents including protocols, ICFs and clinical study plansSchedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actionsCoordinate and manage version control of clinical documents, prioritize multiple tasks and / or projects with limited supervisionFacilitate vendor engagement from RFP distribution through to final contracting and PO set upSetup and organize Sharepoint and central study filesCoordinate training for the assigned clinical studyManage study laboratory sample tracking and vendor management supportAssist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation PackagesSupport Clinical Operations team with specific projectsEffectively communicate with study team members and work closely to address challengesMinimum Qualifications
BS / BA degree or equivalent and at least one year experience in clinical operations in Sponsor company with 1+ years strongly preferredKnowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out proceduresKnowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal RegulationsExperience with eTMF; ability to directly apply essential document knowledge to file documentsEffective communication, organizational and interpersonal / team skillsProficient in MS Excel, Word and PowerPoint. Knowledge of MS project and SharePoint preferred.Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelinesParticipate in inter-departmental workgroups to create or enhance processesStrong attention to quality / detailGood organizational and time management skillsWillingness to work in a flexible environmentPreferred Qualifications
Experience with global studies, using an outsourced CRO modelExperience in clinical drug development with knowledge of First in Human trialsExperience with regulatory affairs, including IND / CTA submissionsExperience working on dermatologyCompany Description
Beacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP / outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.
Beacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.
Company Description
Beacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP / outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.\r\n\r\nBeacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.\r\n\r\nWhether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.