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Clinical Trial Assistant

Company: Cellphire, Inc.
Location: Rockville
Posted on: September 16, 2022

Job Description:

Cellphire Therapeutics is a Rockville, MD-based biotechnology company focused on developing platelet-based products to save lives. Our lead product, Thrombosomes -, is a platelet-based freeze-dried hemostatic. Cellphire's goal is to revolutionize hemostasis management through the development of the next generation of platelet-based products that will efficiently stop bleeding. We believe that our products will ensure platelet availability to all patients regardless of location or environment.We are growing! As we grow, we have identified a need for a Clinical Trials Associate (CTA) who is responsible for performing in-house clinical trial administrative duties in support of the Clinical Operations and Clinical Development departmental objectives. This position requires prior experience or training in clinical research and GCP/ICH guidelines. Working under supervision, you will assist with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned. Prior Clinical Trial Assistant experience is required, a thorough knowledge of the clinical trials process and associated regulations, clinical operations responsibilities and roles are required. The level will depend on skills, experience, education, and knowledge.*As our CTA, you will: ** Assist clinical operations team with the data review and entry, as appropriate* Assist in preparation and organization of study documents (templates, study references, manuals, study communications and presentations)* Assist in the preparation of study specific training materials* File clinical documents and perform duties related to maintenance of clinical research files if requested and approved by Clinical Study Manager and other clinical operations staff* Take meeting minutes for internal team meetings* Assist or lead the coordination of clinical trial oversight with the internal and external stakeholders on the initiation, execution and close out activities in clinical trials execution* Work with Clinical team to perform activities relating to the completion of TMF managed by a Contract Research Organization/s* Communicate with the CRO regarding study metrics and any eTMF issues and follow up on pending items to the time of completion/closure of an issue* Assist in development of study documents and trackers, assist clinical and regulatory staff with IND documents publishing in eCTD format* Ensure filing and maintenance of all regulatory documents* Support internal team meetings by managing team's meetings calendar, organizing the meetings calendars and finalization, and filing of the internal clinical team meeting minutes* Assist, if needed, in preparation of documents for the study investigators and study coordinators* Assist in tracking of clinical trial progress including status update reports, if requested* Identify and escalate issues appropriately; Ensure that all assigned training is completed on time;* Assist in preparation of materials for the Investigator Meetings and meeting logistics as needed* Initiates investigational product shipments to the sites and ensures that PI supplies are adequate for the assigned sites.* Perform other duties as assigned* Assist clinical operations team with the data review and entry, as appropriate* Assist in preparation and organization of study documents (templates, study references, manuals, study communications and presentations)* Assist in the preparation of study specific training materials* File clinical documents and perform duties related to maintenance of clinical research files if requested and approved by Clinical Study Manager and other clinical operations staff* Take meeting minutes for internal team meetings* Assist or lead the coordination of clinical trial oversight with the internal and external stakeholders on the initiation, execution and close out activities in clinical trials execution* Work with Clinical team to perform activities relating to the completion of TMF managed by a Contract Research Organization/s* Communicate with the CRO regarding study metrics and any eTMF issues and follow up on pending items to the time of completion/closure of an issue* Assist in development of study documents and trackers, assist clinical and regulatory staff with IND documents publishing in eCTD format* Ensure filing and maintenance of all regulatory documents* Support internal team meetings by managing team's meetings calendar, organizing the meetings calendars and finalization, and filing of the internal clinical team meeting minutes* Assist, if needed, in preparation of documents for the study investigators and study coordinators* Assist in tracking of clinical trial progress including status update reports, if requested* Identify and escalate issues appropriately; Ensure that all assigned training is completed on time;* Assist in preparation of materials for the Investigator Meetings and meeting logistics as needed* Initiates investigational product shipments to the sites and ensures that PI supplies are adequate for the assigned sites.* Perform other duties as assigned*Qualifications: ** A minimum of 1 - 2 years of experience in a scientific medical field or Contract Research Organization or Biotechnology company* Working knowledge of ICH-GCP and FDA regulations concepts, clinical protocol, Informed consent form, CRFs, TMF and all other associated clinical trial related tools and documents. Working knowledge of Word, Excel, and PowerPoint.* Strong interpersonal and collaboration skills.* Clear and concise verbal and written communication skills with attention to details.* Familiar with drug development, relevant functions, and cross functional activities* Familiar with basic concepts of clinical research including ICH-GCP* Working knowledge of regulatory, clinical, and all associated study related documents* Working knowledge of basic principles and practices of computer applications* Attention to details* Good organizational and time management skills and demonstrated ability to handle multiple tasks and deadlines.* Must have a high degree of customer focus towards internal and external stakeholders.* Demonstrated ability to build and maintain positive relationships with management, peers, sites, and vendors.* BS/BA degree or equivalent in a scientific discipline or healthcare field is preferred but is not required with minimum 1-2 years' experience is strongly preferred or dependent on the level, a minimum combination of experience and training will be taken into consideration. Experience working at small biotechnology company or CRO as a plus.Soft Skills* Clear and concise verbal and written communication skills with strong attention to details.* Good organizational and time management skills and demonstrated ability to handle multiple tasks and deadlines.* Must have a high degree of customer focus towards internal and external stakeholders.* Strong interpersonal and collaboration skills with demonstrated ability to build and maintain positive relationships with management, peers, sites, and vendors.The candidate must be willing to work in a fast-paced biotechnology environment and to work a flexible schedule on short notice. Late-night and weekend work will be required occasionally but not routinely.*What Else You Should Know: *At Cellphire, we care about our employees' physical and financial welfare. Our current benefits package includes:* 100% paid Medical, Dental, and Vision insurance* Flexible Spending Accounts* Life and Disability Insurance* Paid Time Off, Plus Holidays* 401(k) Match* Stock Options* Tuition AssistanceWhat Now?Sound interesting? Take the next step and submit your credentials - a resume and a cover email today. Join us and be part of a company that is making a difference and saving lives.Cellphire is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breast feeding and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability or any other protected status in accordance with all applicable federal, state, and local laws.Job Type: Full-timePay: $45,000.00 - $55,000.00 per yearBenefits:* 401(k)* 401(k) matching* Dental insurance* Flexible spending account* Health insurance* Life insurance* Paid time off* Professional development assistance* Tuition reimbursement* Vision insuranceSchedule:* Monday to FridaySupplemental pay types:* Bonus pay

Keywords: Cellphire, Inc., Rockville , Clinical Trial Assistant, Healthcare , Rockville, Maryland

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