Celerion

The Clinical Project Coordinator will assist with project management and site management by supporting in-house activities for studies or projects managed by Celerion. This includes supporting project initiation, implementation, milestone tracking, and assisting in the production of key project progress reports. | A Bachelor’s degree in a biomedical-related field or life sciences is required, along with excellent communication skills and a high level of organization. Candidates should have knowledge of Good Clinical Practice and relevant regulatory requirements. | Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Are you looking for an opportunity that will make a difference in the future of healthcare? We are seeking a Clinical Project Coordinator to join our Global Clinical Development team! Do you want to learn more? As a Clinical Project Coordinator you will assist with project management and/or site management by supporting in-house activities for studies or projects managed by Celerion. You will support project initiation, project implementation, milestone tracking, and assist in the production of key project progress reports. The primary role of the Clinical Project Coordinator is to support the responsible Clinical Project Manager or Program Director and their designates in their oversight tasks, such as updating and/or reviewing project information system(s), investigator fees, status updates, regulatory submissions and similar duties. This position is part-time and will work approx. 20 hours/week. This is a work-from-home, remote based position from any US geography. \n Primary Responsibilities: Support day-to-day management of studies, ensure within the Study Team that project/study tasks are delivered in time, within the budget, and according to Sponsor/Client expectations, in close cooperation with designated Project Team Support the implementation and maintenance of studies; assist so that Sponsor and Investigator obligations are met and are in compliance with applicable regulatory requirements (including local law) as well as Good Clinical Practice Support in document management (creation, review, collection, filing, forwarding) including submission documents, meeting minutes and Trial Master Files, from Pre-study Phase to Study Closure Support (field) monitors by (but not limited to) preparing checklists, controlling completion status and timelines, updating relevant tracking sheets Create, review, finalize, forward and file meeting minutes for all internal and external study-related meetings. Support in Celerion process improvement Support in-house in performing site feasibility and site qualification visits in order to select qualified sites Support to prepare documents for Site Initiation Visits (SIVs), such as presentation slides Support to prepare documents for Monitoring Visits Support to prepare documents for Close-out Visits Perform content review and quality checks of received documents Cooperate with central TMF team to keep Trial Master File (TMF) up-to-date and track filed documents Support query resolution in a timely manner Support Serious Adverse Event (SAE) reporting according to study specifications Support in document/review study status, site enrolment status As a member of Celerion’s project teams, perform billable work in accordance with Celerion BCDs, SOPs and PGs, and within the relevant timelines Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary Participate and demonstrate proactive involvement in project/study meetings, internal project/study meetings, and other activities enhancing project progress Participate in audits and inspections, including preparation and follow-up activities Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements Requirements: Bachelor’s degree in a biomedical-related field, life sciences or equivalent field Excellent oral and written communication skills in English High level of organization, multi-tasking, judgement and analytical skills Good time management skills to ensure adherence to timelines Profound knowledge of Good Clinical Practice, 21 CRF Part 11, and other relevant regulatory requirements Dedication to quality and reliability Commitment to continuous training and knowledge sharing; proactively keeping up to date with procedural industry standards and international regulatory developments in clinical research Ability to work well independently and as part of a team Maintain confidentiality of Subject data and Sponsor/Client information Computer literate Pay attention to detail, be tactful, and diplomatic Responds to client needs and is focused on client satisfaction Willingness to learn and gain professional experience \n Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

Analyze and interpret clinical trial safety data and compile clinical study reports, lead report quality control and client communication, and ensure regulatory compliance. | Bachelor's degree or equivalent in medical/scientific field, 1-3 years clinical or hospital experience interpreting medical results, strong writing/editing skills, detail-oriented, and US residency. | Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. We are searching for a full-time Medical Writer to work remotely. This role will be home basedanywhere in the United States. Canada and non-US candidates will not be considered. This position will analyze and interpret safety results of clinical trials. Compile, write and edit clinical study reports and other industry documents. Confirm accurate classification of events and medications using standardized coding systems. Responsibilities: • Analyze and interpret all types of medical results including, but not limited to the following: vital signs, clinical laboratory values, adverse events, electrocardiograms (ECGs), diagnostic procedures, and various pharmacodynamic (PD) endpoints. Compile and write Phase I and Phase II clinical trial documents including, but not limited to the following: clinical study reports (CSRs), stand-alone safety narratives, and synoptic CSRs. • Review/evaluate study results to determine whether or not the safety objectives and/or endpoints were met, accurately reflecting the results in the safety text. • Perform peer QC function of safety text prior to inclusion in the CSR. Review reports for completeness and accuracy assuring that the safety text fits into the CSR as whole and recommending changes or rewriting, as appropriate. • As the project Report Lead on a multi-disciplinary scientific team, ensure quality and on-time delivery of scientific reports. • Monitor content of editorial comments received prior to incorporation into the report to assure report text comments are accurate and support the objectives and/or endpoints. • Assure deliverables are compliant with applicable regulatory standards (i.e. Good Clinical Practice, International Conference on Harmonisation guidelines) and client specifications. • Use technology to work with international teams (e.g. Veeva, Microsoft® 365 applications, SharePoint®, and SmartSheet). • Lead Project-related client communication • Interact with internal departments (e.g. data management, project management, business development, etc.). • Participate in functions required to ensure success of department and/or market segment team. Requirements: • Bachelor's degree and/or professional license in a medical or scientific field (RN, BS, MS, MPH) required or equivalent experience. • 1-3 years experience in hospital/clinical setting or interpreting medical or clinical results. • Professional writing and editing skills for accurate and concise reporting of clinical trial results; ability to interpret and present data in preparing a coherently written document. • Detail-oriented, thorough, and methodical. • Ability to work without close supervision and ability to work under pressure. • Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines. • Excellent communication/ interpersonal skills. • Knowledge of medical, pharmaceutical, and/or clinical research concepts preferred. • Currently lives in the United States. Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

Analyze clinical trial safety data and write/edit clinical study reports ensuring regulatory compliance and quality deliverables. | Bachelor's or equivalent in medical/scientific field, 1-3 years clinical experience, strong writing/editing skills, detail-oriented, US residency. | Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. We are searching for a full-time Medical Writer to work remotely. This role will be home based anywhere in the United States. Canada and non-US candidates will not be considered. This position will analyze and interpret safety results of clinical trials. Compile, write and edit clinical study reports and other industry documents. Confirm accurate classification of events and medications using standardized coding systems. Responsibilities: • Analyze and interpret all types of medical results including, but not limited to the following: vital signs, clinical laboratory values, adverse events, electrocardiograms (ECGs), diagnostic procedures, and various pharmacodynamic (PD) endpoints. Compile and write Phase I and Phase II clinical trial documents including, but not limited to the following: clinical study reports (CSRs), stand-alone safety narratives, and synoptic CSRs. • Review/evaluate study results to determine whether or not the safety objectives and/or endpoints were met, accurately reflecting the results in the safety text. • Perform peer QC function of safety text prior to inclusion in the CSR. Review reports for completeness and accuracy assuring that the safety text fits into the CSR as whole and recommending changes or rewriting, as appropriate. • As the project Report Lead on a multi-disciplinary scientific team, ensure quality and on-time delivery of scientific reports. • Monitor content of editorial comments received prior to incorporation into the report to assure report text comments are accurate and support the objectives and/or endpoints. • Assure deliverables are compliant with applicable regulatory standards (i.e. Good Clinical Practice, International Conference on Harmonisation guidelines) and client specifications. • Use technology to work with international teams (e.g. Veeva, Microsoft® 365 applications, SharePoint®, and SmartSheet). • Lead Project-related client communication • Interact with internal departments (e.g. data management, project management, business development, etc.). • Participate in functions required to ensure success of department and/or market segment team. Requirements: • Bachelor's degree and/or professional license in a medical or scientific field (RN, BS, MS, MPH) required or equivalent experience. • 1-3 years experience in hospital/clinical setting or interpreting medical or clinical results. • Professional writing and editing skills for accurate and concise reporting of clinical trial results; ability to interpret and present data in preparing a coherently written document. • Detail-oriented, thorough, and methodical. • Ability to work without close supervision and ability to work under pressure. • Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines. • Excellent communication/ interpersonal skills. • Knowledge of medical, pharmaceutical, and/or clinical research concepts preferred. • Currently lives in the United States. Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.