Become A Clinical Research Specialist

* Will collect and integrate data regarding patients condition for review by the physician investigator.
* Participates in listing and clarifying questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations, and study procedures.
* Reviews inclusion/exclusion criteria to assure subject eligibility, and reviews with physician investigator for final sign-off.
* Reviews and verifies required source documents in subjects medical record to confirm study eligibility.
* Reviews study protocol, informed consent form, and follow-up procedures with potential study subjects.
* Prepares case report forms and collects source documents for sponsor or audit review.
* Assesses subject compliance with the test article and follow-up visits.
* Abstracts data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets.
* Attends and participates in investigator meetings.
* Schedules and coordinates pre-study site visits.
* Monitors enrollment goals and modifies recruitment plan as necessary.
* Maintains patient screening/enrollment logs and appropriately updates sponsors, CROs and/or SMOs.
* Assures that all screening, eligibility and enrollment procedures are performed.
* Consent patients.
* Follows randomization procedures as per protocol.
* Schedules subjects for follow-up visits.
* Reviews diaries and questionnaires completed by subject.
* Ensures appropriate specimen collection, batching and shipping as required.
* Documents and maintains all study-related procedures, processes and events by planning and design of new forms/source document tools to be used in protocol implementation.
* Documents protocol deviations and exemptions.
* Obtains and reviews original source documents as needed.
* Sanford Research is a multi-site institution and occasional local travel between sites may be required

* Develops or provides input into the requiredclinical documents (such as the Clinical Study Management Plan, the ClinicalInvestigational Plan, study objectives, study budget and project schedule,study training materials, and study reports) in collaboration withinvestigators and the cross-functional study team to meet business needs.
* Responsible for identification of datacollection and data reporting requirements to assure clinical study objectivesare achievable.
* Drives collaboration of a study leadershipteam to assure high quality and successful project delivery.
* Interfaces with key functional areas in orderto align the clinical study with needs for other business areas (Marketing,research, regulatory, development, patient management, reimbursement.)
* Develops therapeutic and device operationknowledge and applies this knowledge to clinical study processes.
* Facilitates meetings with health careprofessionals, consultants and internal scientific or tactical committees.
* Cultivates strong relationship with clinicalinvestigators and site staff.
* Collaborates with clinical field organizationto drive study execution and data quality initiatives.
* Evaluates clinical data/evidence and maydetermine application of study results
* May provide input and support for planning post-clinical activities,educational activities, and market launch of products
* Oversee evidence dissemination and strategicplanning for clinical projects / programs.
* Convenes investigator conferences toreview study findings and advise on direction.
* May author/co-author results of studies in themedical literature and/or presents at scientific meetings.
* May interface with regulatory agenciesincluding pre
* IDE meetings with the Food and Drug Administration (FDA) andprepares and/or conducts presentations to FDA panel reviewers regardingrequirements and results of the study.
* Critically evaluates study progress andmetrics, collaborating with crossfunctional teams to identify risks and mitigation plans, if applicable.
* Participates in or drives process improvementinitiatives.
* MUST HAVE

* Other duties may be assigned.
* Under supervision of a Clinical Affairs' team member, provides support on study tasks with relevant departments (R&D, Regulatory Affairs, Medical Affairs, Validations, Product Support, Marketing) to aid in design and preparation of clinical and analytical in vitro diagnostic device performance study plans, protocols, statistical data analysis plans, and associated study data collection forms.
* Remains current with regulatory requirements for in vitro diagnostic products.
* With some supervision, assists in all activities related to the set-up, initiation, execution and close-out of in vitro diagnostic device clinical trials including specimen collection, timely review and analysis of data generated.
* Provides assistance during on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data.
* Communicates with study investigators via phone, fax, email and/or letters regarding activities in all phases of the study.
* Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials.
* Participate in coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database.
* Support preparation of up-to-date clinical study progress.
* Supports the tracking of study budgets, site contract origination and compliance approval for studies.
* Assists Clinical Affairs Supervisor with preparation of responses to regulatory agencies.
* Assists in the preparation of scientific abstracts, posters, and publications reporting results of the clinical studies.
* Equal Employment Opportunity Statement
* Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace.
* All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
* EEO is the Law
* Applicants and employees are protected under Federal law from discrimination.
* To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .
* Pay Transparency Non
* Discrimination Provision
* Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision.
* To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

* Screen participants for minimal risk studies.
* screen participants for studies with greater than minimal risk, under supervision.
* Maintain subject level documentation for minimal risk studies, or for other studies under direction.
* Schedule participants and conduct visits for minimal risk studies independently.
* Improve systems related to specimen handling.
* May collect, prepare, process,transport, ship, and maintain inventory of research specimens and train others in these tasks.
* Collaborate to maintain appropriate study-level documentation including regulatory binders,enrollment logs, patient registration in the system of record, etc.
* Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
* Evaluate processes to identify issues related to recruitment and retention rates.
* Conduct and document consent for participants in minimal risk studies.
* May conduct consent for studies with greater than minimal risk, under the supervision of a CRC or CRNC.
* Prepare for study monitoring and study audit visits.
* Collect, prepare or process adverse event information under supervision.
* Provide input for adverse event reports.
* Provide input for DUHS IRB documents such as consent forms,protocols, and continuing reviews.
* Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications.
* Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations.
* Understand that the safety of research participants is a priority
* Identify and explain the risk and benefits to a subject as these pertain to your clinical trial.
* Map a protocol's data flow plan: data capture, storage, management,quality, and preparation for analysis.
* Train others on study team in use of technologies and software, and in completion of ECRFs.
* Assist with the development of data collection documents to standardize process.
* Use EDC systems and enter data accurately.
* Use required processes,policies, and systems to ensure data security and provenance.
* Assist in investigating incomplete,inaccurate or missing data/documents to ensure accuracy and completeness of data.
* Follow SOPs for data QA.
* Conduct literature reviews under the direction of the CRC, CRNC, or PI.
* Determine operational/statistical elements needed for the conduct of clinical and translational studies.
* Assist research colleagues in identifying efficiencies and improving process.
* Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
* Maintain Duke and project specific training requirements.
* Ensure participant care expenses have appropriate financial routing in a timely manner.
* Monitor financial study milestones and report appropriately.
* Coordinate with financial teams, PRMO, etc.and participate in budget development as appropriate.
* Assist with study budgets.
* Maintain study's compliance with institutional requirements and other policies (e.g.,NIH Public Access policy,ct.gov, Research Data Security Plans, Social Media policy, etc.).
* Assist with the development of protocol-specific systems and documents including process flows,training manuals, standard operating procedures, and case report forms.
* Prepare for closeout and document storage
* Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.
* Participate in study team meetings.
* Respond to routine questions related to study protocol and refer more complex questions to others as appropriate.
* Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.
* Support minimal risk research projects in collaboration with CRCs.
* One project involves recruitment from multiple local Duke Clinics.
* Responsibilities include conducting research visits under CRC guidance, phlebotomy, completing study related documentation,monitoring inventory of supplies, ordering supplies, tracking and transporting specimens,and reviewing and reconciling financial reports.
* Additional responsibilities include working with PIon grant and manuscript preparation including compiling and editing documents, and preparing reports.
* Perform other related duties incidental to the work described herein.
* The above statements describe the general nature and level of work being performed by individuals assigned to this classification.
* This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified

* Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.
* Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
* Coordinates research projects at an institutional or departmental level.
* Communicates project status and improvement areas with leadership in a timely manner and approaches and communicates improvement areas in a solution-based manner.
* Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report from development, budget development, and coordination of departmental research committees.
* Provides guidance regarding project planning, project logistics, and project implementation.
* Serves as an internal consultant for specific departmental activities.
* Provides research writing activities such as, developing scientific documents for abstracts, publications, presentations, funding applications, and study protocols.
* May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
* Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA)
* local Institutional Review Board.
* Maintains research practices using Good Clinical Practice (GCP) guidelines.
* Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
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