BlueRock Therapeutics
Senior Clinical Trial Coordinator
BlueRock Therapeutics, Cambridge, Massachusetts, us, 02140
Who is BlueRock?BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique
cell+gene
platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases. The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel
cell+gene
platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.What Are We Doing?Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives.BlueRock Therapeutics is seeking a Senior Clinical Trial Coordinator (Sr. CTC) who is a highly motivated person with prior experience supporting a clinical trial at a sponsor company, possesses excellent computer skills, attentive to details, strong organizational skills, and is able to communicate effectively in a fast-paced environment.Major responsibilities for this position will include supporting ongoing clinical trials and ensuring there is operation continuity across ongoing and future clinical trials. The position will be a member of the Clinical Operations group, reporting to the Director of Clinical Operations.Responsibilities:
Provide support to the Clinical Trial Managers on assigned clinical trials.Manage and support electronic Trial Master File (eTMF) activities.Organize and prepare relevant team meetings, associated agendas, and generate meeting minutes, including tracking and following up of action items until resolution.Support with development and review of study documents (e.g. ICF, study plans, CRFs).Maintain and track study-level training documentation.Assist with coordination and tracking of study progress including creation and maintenance of study trackers and tools.Maintain and update clinicaltrials.gov registry and other registries as applicable.Effectively and efficiently interact with internal, clinical site and vendor personnel.Assist Clinical Trial Manager with vendor management and communication.Adhere and follow involved Standard Operating Procedures (SOPs) and Good Clinical Practices (GCP).Assist with in-house coordination of activities related to conduct of clinical trials.Seek opportunities to learn and request feedback on tasks performed from team members.Track progress across multiple programs and communicate this to internal and external stakeholders.Requirements:
Minimum of a Bachelor's degree is required; Bachelor's in healthcare or a scientific field is preferredMinimum of 2 years prior experience supporting a clinical trial as a clinical trial coordinator or equivalent at a Sponsor company is requiredFamiliarity with eTMF, CTMS, and EDC systemsEnthusiastic to expand knowledge of clinical trial management proceduresDemonstrate problem-solving skills, including the identification of problems and proposed solutions, in consultation with more senior team membersPossess good verbal and written skills and seek information when neededStrong computer skills, attention to detail, organizational skills, and ability to communicate effectively in a fast-paced environment#LI-AL1BlueRock Therapeutics Company Culture Highlights
Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023 Winner of Comparably's Award for Best Company for Diversity 2022 Winner of Comparably's Award for Best Company for Women 2022 Winner of Comparably's Award for Best CEO 2022 BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably. Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/Equal Opportunity Workplace:
At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
cell+gene
platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases. The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel
cell+gene
platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.What Are We Doing?Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives.BlueRock Therapeutics is seeking a Senior Clinical Trial Coordinator (Sr. CTC) who is a highly motivated person with prior experience supporting a clinical trial at a sponsor company, possesses excellent computer skills, attentive to details, strong organizational skills, and is able to communicate effectively in a fast-paced environment.Major responsibilities for this position will include supporting ongoing clinical trials and ensuring there is operation continuity across ongoing and future clinical trials. The position will be a member of the Clinical Operations group, reporting to the Director of Clinical Operations.Responsibilities:
Provide support to the Clinical Trial Managers on assigned clinical trials.Manage and support electronic Trial Master File (eTMF) activities.Organize and prepare relevant team meetings, associated agendas, and generate meeting minutes, including tracking and following up of action items until resolution.Support with development and review of study documents (e.g. ICF, study plans, CRFs).Maintain and track study-level training documentation.Assist with coordination and tracking of study progress including creation and maintenance of study trackers and tools.Maintain and update clinicaltrials.gov registry and other registries as applicable.Effectively and efficiently interact with internal, clinical site and vendor personnel.Assist Clinical Trial Manager with vendor management and communication.Adhere and follow involved Standard Operating Procedures (SOPs) and Good Clinical Practices (GCP).Assist with in-house coordination of activities related to conduct of clinical trials.Seek opportunities to learn and request feedback on tasks performed from team members.Track progress across multiple programs and communicate this to internal and external stakeholders.Requirements:
Minimum of a Bachelor's degree is required; Bachelor's in healthcare or a scientific field is preferredMinimum of 2 years prior experience supporting a clinical trial as a clinical trial coordinator or equivalent at a Sponsor company is requiredFamiliarity with eTMF, CTMS, and EDC systemsEnthusiastic to expand knowledge of clinical trial management proceduresDemonstrate problem-solving skills, including the identification of problems and proposed solutions, in consultation with more senior team membersPossess good verbal and written skills and seek information when neededStrong computer skills, attention to detail, organizational skills, and ability to communicate effectively in a fast-paced environment#LI-AL1BlueRock Therapeutics Company Culture Highlights
Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023 Winner of Comparably's Award for Best Company for Diversity 2022 Winner of Comparably's Award for Best Company for Women 2022 Winner of Comparably's Award for Best CEO 2022 BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably. Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/Equal Opportunity Workplace:
At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.