Clinical Research Associate II

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJoin Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of InnovationWe have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.What You’ll Do Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).6305918 Senior Scientist – Cell Culture / IPSC ![CDATA[ p strong em This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. /em /strong /p htmlhead/headbodypstrongWork Schedule/strong/pFirst Shift (Days)pstrongEnvironmental Conditions/strong/pAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Settingp/ppstrongJob Description/strong/pp/ppstrongSenior Scientist – Cell Culture / IPSC/strong/ppShift: Full-Time; Monday – Friday; 8am-5pm EST/pp/ppstrongONSITE:/strong/ppThis is a fully onsite role based at our customer’s site in strong(Medford, MA)./strong We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.  /ppMust be legally authorized to work in the United States without sponsorship. /ppMust be able to pass a comprehensive background check, which includes a drug screening. /ppAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future./ppThermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner./ppOur Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies./pp/ppstrongKey responsibilities:/strong/pulliMust havestrong industrial/strong cell culture experience especially in expanding and differentiating iPSC in an industry environment. /liliCell Culture, Aseptic Technique, expansion and cryopreservation experience is a strongMUST HAVE/strong/liliCompletes experiments in a reliable, consistent manner /liliDemonstrates high level of attention to details /liliPerforms initial analysis of experimental data and interprets immediate experimental outcomes /liliRecords experiments and results in laboratory notebooks (including all electronic systems) in accordance with lab procedures /liliRecognizes problems and suggests experiments to troubleshoot issues /liliExecute on new ideas to improve workflows, consistency and efficiency of the cell culture processes /liliClearly and effectively communicates (both written and verbal) results /liliLeverages technical experience to help prioritize studies, based on Project impact/liliPerforms basic statistical analysis of experimental data, where appropriate/liliConducts own experimental troubleshooting on routine problems/liliAssists with publication and patent submission processes/liliSurveys relevant scientific literature to maintain awareness of issues and trends within the field/liliPresent studies effectively at internal Group/Department or Project Team research meetings/liliPerforms other duties as assigned/li/ulp/ppstrongEducation and Experience:/strong/pulliBachelor's degree in lab sciences such as Cell Biology, Biochemistry, Biology, Molecular Biology or similar/lilistrongSr. Scientist:/strong Previous experience that provides the knowledge, skills, and abilities to perform the job strong(comparable to 4+ years’)/strong/liliOR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job strong(comparable to 2+ years’)/strong/li/ulpIn some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role./pp/ppstrongKnowledge, Skills and Abilities:/strong/pulliProven technical proficiency and demonstrated skill in conducting and interpreting experiments including the expansion and differentiation of human iPS cell models./liliIndustrial cell culture experience is a key to this position./liliCell Culture, Aseptic Technique, expansion and cryopreservation experience is a strongMUST HAVE/strong/liliExperience with advanced cell culture techniques to culture human iPS cells. /liliUses technical knowledge to design and execute follow-up experiments/liliDemonstrated understanding of analysis and interpretation of experimental data with proficient problem solving and protocol refinement/liliExperience with advanced cell culture techniques to culture human cells /liliAbility and willingness to work rotating weekend shifts according to business needs /liliAdaptive to a time-line driven work and able to work in a dynamic (changing SOP) environment. /liliMultitasking skills, attention to details and ability to work in a collaborative team environment /liliGreat interpersonal/teamwork skills and positive attitude /liliOften deployed to investigations with more significant consequences and need for reliability/liliEffective communicator (written and verbal), especially within their technical area(s)/li/ulp/ppstrongWorking Environment: /strong/ppBelow is listed the working environment/requirements for this role:/ppAble to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner./ppAble to work upright and stationary and/or standing for typical working hours./ppAble to lift and move objects up to 25 pounds/ppAble to work in non-traditional work environments./ppAble to use and learn standard office equipment and technology with/ppproficiency./ppMay have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments./ppAble to perform successfully under pressure while prioritizing and handling multiple projects or activities./ppstrongBenefits/strong/ppWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!/ppPhysical Requirements:br Ability to work in an upright and /or stationary position for 6-8 hours per day.br Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.br Occasional mobility needed.br Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.br Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.br Ability to access and use a variety of computer software developed both in-house and off-the-shelf.br Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.br Frequently interacts with others to obtain or relate information to diverse groups.br Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.br Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.br Regular and consistent attendance.brbrWhy Join Us?brWhen you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.brbrApply today to help us deliver tomorrow’s breakthrough./pp/ppstrongCompensation and Benefits/strong/pThe salary range estimated for this position based in Massachusetts is $95,000.00–$110,000.00.p/ppThis position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:/pullipA choice of national medical and dental plans, and a national vision plan, including health incentive programs/p/lilipEmployee assistance and family support programs, including commuter benefits and tuition reimbursement/p/lilipAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy/p/lilipRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan/p/lilipEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount/p/li/ulp/ppFor more information on our benefits, please visit: ahttps://jobs.thermofisher.com/global/en/total-rewards/a/pp/pp/pp/pp/pp/pp/pp/pp/pp/pp/pp/pp/p/body/html]] Medical Affairs Group Biotechnology Full-time Medford United States US https://mygwork.com/jobs/thermo-fisher-scientific-senior-scientist-cell-culture-ipsc?src=linkedinutm_source=linkedinutm_medium=referralutm_campaign=jobs Thermo Fisher Scientific ![CDATA[ p strong em This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. /em /strong /p htmlhead/headbodypstrongWork Schedule/strong/pFirst Shift (Days)pstrongEnvironmental Conditions/strong/pAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Settingp/ppstrongJob Description/strong/pp/ppstrongSenior Scientist – Cell Culture / IPSC/strong/ppShift: Full-Time; Monday – Friday; 8am-5pm EST/pp/ppstrongONSITE:/strong/ppThis is a fully onsite role based at our customer’s site in strong(Medford, MA)./strong We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.  /ppMust be legally authorized to work in the United States without sponsorship. /ppMust be able to pass a comprehensive background check, which includes a drug screening. /ppAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future./ppThermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner./ppOur Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies./pp/ppstrongKey responsibilities:/strong/pulliMust havestrong industrial/strong cell culture experience especially in expanding and differentiating iPSC in an industry environment. /liliCell Culture, Aseptic Technique, expansion and cryopreservation experience is a strongMUST HAVE/strong/liliCompletes experiments in a reliable, consistent manner /liliDemonstrates high level of attention to details /liliPerforms initial analysis of experimental data and interprets immediate experimental outcomes /liliRecords experiments and results in laboratory notebooks (including all electronic systems) in accordance with lab procedures /liliRecognizes problems and suggests experiments to troubleshoot issues /liliExecute on new ideas to improve workflows, consistency and efficiency of the cell culture processes /liliClearly and effectively communicates (both written and verbal) results /liliLeverages technical experience to help prioritize studies, based on Project impact/liliPerforms basic statistical analysis of experimental data, where appropriate/liliConducts own experimental troubleshooting on routine problems/liliAssists with publication and patent submission processes/liliSurveys relevant scientific literature to maintain awareness of issues and trends within the field/liliPresent studies effectively at internal Group/Department or Project Team research meetings/liliPerforms other duties as assigned/li/ulp/ppstrongEducation and Experience:/strong/pulliBachelor's degree in lab sciences such as Cell Biology, Biochemistry, Biology, Molecular Biology or similar/lilistrongSr. Scientist:/strong Previous experience that provides the knowledge, skills, and abilities to perform the job strong(comparable to 4+ years’)/strong/liliOR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job strong(comparable to 2+ years’)/strong/li/ulpIn some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role./pp/ppstrongKnowledge, Skills and Abilities:/strong/pulliProven technical proficiency and demonstrated skill in conducting and interpreting experiments including the expansion and differentiation of human iPS cell models./liliIndustrial cell culture experience is a key to this position./liliCell Culture, Aseptic Technique, expansion and cryopreservation experience is a strongMUST HAVE/strong/liliExperience with advanced cell culture techniques to culture human iPS cells. /liliUses technical knowledge to design and execute follow-up experiments/liliDemonstrated understanding of analysis and interpretation of experimental data with proficient problem solving and protocol refinement/liliExperience with advanced cell culture techniques to culture human cells /liliAbility and willingness to work rotating weekend shifts according to business needs /liliAdaptive to a time-line driven work and able to work in a dynamic (changing SOP) environment. /liliMultitasking skills, attention to details and ability to work in a collaborative team environment /liliGreat interpersonal/teamwork skills and positive attitude /liliOften deployed to investigations with more significant consequences and need for reliability/liliEffective communicator (written and verbal), especially within their technical area(s)/li/ulp/ppstrongWorking Environment: /strong/ppBelow is listed the working environment/requirements for this role:/ppAble to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner./ppAble to work upright and stationary and/or standing for typical working hours./ppAble to lift and move objects up to 25 pounds/ppAble to work in non-traditional work environments./ppAble to use and learn standard office equipment and technology with/ppproficiency./ppMay have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments./ppAble to perform successfully under pressure while prioritizing and handling multiple projects or activities./ppstrongBenefits/strong/ppWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!/ppPhysical Requirements:br Ability to work in an upright and /or stationary position for 6-8 hours per day.br Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.br Occasional mobility needed.br Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.br Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.br Ability to access and use a variety of computer software developed both in-house and off-the-shelf.br Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.br Frequently interacts with others to obtain or relate information to diverse groups.br Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.br Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.br Regular and consistent attendance.brbrWhy Join Us?brWhen you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.brbrApply today to help us deliver tomorrow’s breakthrough./pp/ppstrongCompensation and Benefits/strong/pThe salary range estimated for this position based in Massachusetts is $95,000.00–$110,000.00.p/ppThis position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:/pullipA choice of national medical and dental plans, and a national vision plan, including health incentive programs/p/lilipEmployee assistance and family support programs, including commuter benefits and tuition reimbursement/p/lilipAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy/p/lilipRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan/p/lilipEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount/p/li/ulp/ppFor more information on our benefits, please visit: ahttps://jobs.thermofisher.com/global/en/total-rewards/a/pp/pp/pp/pp/pp/pp/pp/pp/pp/pp/pp/pp/p/body/html]]