[Remote] Float Clinical Research Coordinator II

Note: The job is a remote job and is open to candidates in USA. Fresenius Medical Care is a leading healthcare company, and they are seeking a Float Clinical Research Coordinator II. This role is responsible for the collection and analysis of clinical research data, ensuring compliance with protocols and regulations while coordinating subject care throughout the study process.ResponsibilitiesAssists with the determination of the guidelines for the collection of clinical data and coordinates and implements procedures and processes for data collectionCoordinates all aspects of study subject care from pre-screening through study completion as defined by the protocol and Principal Investigator (PI) delegationProtect the rights and the well-being of subjects enrolled in studiesEnsures thorough, individualized, protocol-based study subject education on all study process requirements including but not limited to: informed consent, study participation obligations, appropriate use of investigational product, safety, privacy, rights and responsibilitiesDevelops processes for methodically monitoring the status of study subjects as they progress through the study’s timeline of activitiesRegularly evaluates the study subjects’ condition and communicates/documents concerns to PI to ensure subject safetyAccurately documents study subject activities as outlined by the protocolMaintains documents according to applicable HIPAA and regulatory requirementsImplements study-specific quality goals and practicesActs as the point of contact or lead person in a facility/practice to oversee protocol complianceProactively addresses and acts upon adverse event or patient safety issues according to the appropriate procedureMaintains study site environmental integrity including safe handling of biological specimens as well as study product procurement, administration, and storageParticipates as needed in study related, internal, or State/Federal surveys and auditsMaintains integrity of Fresenius Medical Care, practice and study-specific medical, administrative, and operational recordsTroubleshoots protocol, and strategizes with all participants at every level of the study in order to assure quality study outcomesServes as primary point of contact between sponsor, Clinical Research Organization (CRO), PI and clinical staffAdheres to SOP and GCP and all regulatory practices as established by law and company policies and proceduresCoordinates logistics of activity for multiple, concurrent studies at multiple study sitesParticipates in the recruitment, interview process, and education of new research personnel as directedCoordinates with facility or practice manager to educate new clinical staff on study specific responsibilities and protocol tasksMaintains mandatory training requirements according to guidelines/conditions set by, for example, the International Air Transport Association (IATA), GCP, etcOversees performance of delegated study related activities by all licensed personnel, or direct patient care staffCoordinates and resolves potentially conflicting patient care treatment protocols involving the clinic and support staffCollaborates with appropriate management to ensure research activities are not inappropriately or illegally billed, and that research activities are minimally disruptive to clinic routineTracks and coordinates potential study site education funds and assists with disbursementFacilitates positive relationships with Medical Director and appropriate managementSupports physicians by communicating initiatives, policies and procedures; ensures attending physician receives notifications of patients’ participationProvides the clinic Governing Body and clinic staff with appropriate study documentationMaintains up-to-date knowledge regarding the operation of study specific equipment and technologyImplements study procedures around the parameters of the dialysis machines and dialysis processProvides relevant information regarding the projected regional costs of treatments, projected enrollment capabilities, anticipated risks/benefits at specific study sites, logistical impediments, etc. for use in study contract and budget negotiationsEnsures study enrollment goals are met, study resources are used efficiently, and the study budget is adhered to and covers the cost of research at study sitesCompletes the clinical trials management system and electronic/paper case report forms in an accurate and timely mannerEnsures the appropriate maintenance of study subject payment recordsCompletes application documents (e.g. internal, Institutional Review Board (IRB) site submission, sponsor required) and coordinates ongoing document processing throughout the entire study orCoordinates with regulatory monitors, responds to mentoring inquiresCompletes study subject records in an accurate and timely completion of all applicable study subject recordsOther duties as assignedSkillsMust be comfortable with 80% travelResponsible for the collection, accuracy and validity of clinical research data for assigned clinical studies in accordance with the study protocol and timelinesPerforms a variety of complex activities to appropriately compile, document and analyze clinical research data, using the subject's medical record as sourceNegotiates differing priorities with multiple players whilst balancing a multiple number of tasks and timelines under a complex network of rules and regulationsEnsures research studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP, ICH, and FDA guidelinesPractices cost containment strategies while ensuring appropriate enrollment of subjects in studiesAssists with the determination of the guidelines for the collection of clinical data and coordinates and implements procedures and processes for data collectionCoordinates all aspects of study subject care from pre-screening through study completion as defined by the protocol and Principal Investigator (PI) delegationProtect the rights and the well-being of subjects enrolled in studiesEnsures thorough, individualized, protocol-based study subject education on all study process requirements including but not limited to: informed consent, study participation obligations, appropriate use of investigational product, safety, privacy, rights and responsibilitiesDevelops processes for methodically monitoring the status of study subjects as they progress through the study's timeline of activitiesRegularly evaluates the study subjects' condition and communicates/documents concerns to PI to ensure subject safetyAccurately documents study subject activities as outlined by the protocolMaintains documents according to applicable HIPAA and regulatory requirementsImplements study-specific quality goals and practicesActs as the point of contact or lead person in a facility/practice to oversee protocol complianceProactively addresses and acts upon adverse event or patient safety issues according to the appropriate procedureMaintains study site environmental integrity including safe handling of biological specimens as well as study product procurement, administration, and storageParticipates as needed in study related, internal, or State/Federal surveys and auditsMaintains integrity of Fresenius Medical Care, practice and study-specific medical, administrative, and operational recordsTroubleshoots protocol, and strategizes with all participants at every level of the study in order to assure quality study outcomesServes as primary point of contact between sponsor, Clinical Research Organization (CRO), PI and clinical staffAdheres to SOP and GCP and all regulatory practices as established by law and company policies and proceduresCoordinates logistics of activity for multiple, concurrent studies at multiple study sitesParticipates in the recruitment, interview process, and education of new research personnel as directedCoordinates with facility or practice manager to educate new clinical staff on study specific responsibilities and protocol tasksMaintains mandatory training requirements according to guidelines/conditions set by, for example, the International Air Transport Association (IATA), GCP, etcOversees performance of delegated study related activities by all licensed personnel, or direct patient care staffCoordinates and resolves potentially conflicting patient care treatment protocols involving the clinic and support staffCollaborates with appropriate management to ensure research activities are not inappropriately or illegally billed, and that research activities are minimally disruptive to clinic routineTracks and coordinates potential study site education funds and assists with disbursementFacilitates positive relationships with Medical Director and appropriate managementSupports physicians by communicating initiatives, policies and procedures; ensures attending physician receives notifications of patients' participationProvides the clinic Governing Body and clinic staff with appropriate study documentationMaintains up-to-date knowledge regarding the operation of study specific equipment and technologyImplements study procedures around the parameters of the dialysis machines and dialysis processProvides relevant information regarding the projected regional costs of treatments, projected enrollment capabilities, anticipated risks/benefits at specific study sites, logistical impediments, etc. for use in study contract and budget negotiationsEnsures study enrollment goals are met, study resources are used efficiently, and the study budget is adhered to and covers the cost of research at study sitesCompletes the clinical trials management system and electronic/paper case report forms in an accurate and timely mannerEnsures the appropriate maintenance of study subject payment recordsCompletes application documents (e.g. internal, Institutional Review Board (IRB) site submission, sponsor required) and coordinates ongoing document processing throughout the entire studyCoordinates with regulatory monitors, responds to mentoring inquiriesCompletes study subject records in an accurate and timely completion of all applicable study subject recordsHighly prefer someone who lives in the Northeast, as they will be traveling to Michigan, Mississippi, Louisiana, Indiana and New JerseyGraduate of a technical program in healthcare, AA in Life Sciences or other health related field, preferred2 to 4 years of clinical research experience, or has successfully performed in the role of Clinical Research Coordinator I for a minimum of 3 years and demonstrated outstanding performance through performance evaluations, certification and other job performance measuresCritical care, nephrology and/ or cardiac experience desirableWilling to pursue CCRC or CCRP certification when eligibleCurrent state licensure, if applicableGood computer skills: Microsoft Office minimallyExcellent communication and organizational skillsAbility to work independently, and exhibit diplomacy and problem solving skills in the performance of this roleCompany OverviewFresenius Medical Care is a healthcare company that provides dialysis treatment for those with chronic kidney diseases. It was founded in 1912, and is headquartered in Bad Homburg, Hessen, DEU, with a workforce of 10001+ employees. Its website is https://www.freseniusmedicalcare.com.