Title: FSP - Clinical Research Associate 2 Location: United States Job Description: Our FSP team is currently seeking Unblinded CRAs with 1-3 years of monitoring! Candidates must resided within the United States. 8-10 days on site per month being a mix of onsite and remote. Open to West coast, Central and East Coast major hub locations. WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities: - Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned - - Responsible for all aspects of site management as prescribed in the project plans - General On-Site Monitoring - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study - Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements - Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data - Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested - Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs - Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management - Assist with training of new employees, eg. co-monitoring - Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned - Perform other duties as assigned by management Requirements - University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) - 1+ years of Clinical Monitoring experience - 50-60% overnight travel The important thing for us is you are comfortable working in an environment that is: - Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. - Changing priorities constantly asking you to prioritize and adapt on the spot. - Teamwork and people skills are essential for the study to run smoothly. - Technology based. We collect our data directly into an electronic environment. Work Environment: - Work is performed in an office environment with exposure to electrical office equipment. - Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: - Ability to sit for extended periods and operate a vehicle safely. - Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. - Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. - Ability to access and use a variety of computer software developed both in-house and off-the-shelf. - Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. - Regular and consistent attendance. - Varied hours may be required. - Target Pay Range: $100-115K based on job title #LI - Remote Applications will be accepted on an ongoing basis. Learn more about our EEO & Accommodations request here.

• Support study start-up activities (feasibility, site selection, regulatory submissions) • Assist in building and maintaining study timelines and plans • Coordinate investigator meetings and support site activation • Oversee day-to-day trial operations across sites/countries • Ensure compliance with ICH-GCP and regulatory requirements • Monitor study progress, enrollment, and data quality • Identify risks and escalate as needed • Ensure audit/inspection readiness and quality standards • Review clinical data and support reporting to sponsors • Contribute to study reports and documentation

Role Description Als Studienärztin / Studienarzt (m/w/d) unterstützt du die Durchführung klinischer Evaluationsstudien zur Validierung digitaler Gesundheitsanwendungen. Du arbeitest eng mit unserem interdisziplinären Sidekick-Team zusammen. Dein Fokus liegt insbesondere auf der medizinischen Vorprüfung, dem Screening und der Begleitung potenzieller Studienteilnehmer:innen. Du trägst damit entscheidend dazu bei, dass unsere Studien sorgfältig, patient:innenzentriert und in Übereinstimmung mit dem Studienprotokoll durchgeführt werden. - Vorprüfung der Vorauswahl und Screening potenzieller Studienteilnehmer:innen, um die Eignung gemäß Studienprotokoll sicherzustellen - Begleitung der Randomisierung, Planung elektronischer Fragebögen sowie Verwaltung studienbezogener administrativer Aufgaben - Enge Zusammenarbeit mit dem interdisziplinären Sidekick-Team, insbesondere mit Clinical, Research und Product - Regelmäßige Abstimmung mit dem leitenden Studienarzt / der leitenden Studienärztin bzw. Principal Investigator, um den Studienfortschritt in Übereinstimmung mit dem Studienprotokoll sicherzustellen - Sicherstellung hoher klinischer und wissenschaftlicher Standards während des gesamten Studienprozesses Qualifications - Abgeschlossenes Medizinstudium mit relevanter klinischer Erfahrung als Ärztin / Arzt - Erfahrung in der Durchführung klinischer Studien von Vorteil - Patientenzentrierte, empathische Kommunikation - Starke organisatorische Fähigkeiten und eine sehr sorgfältige Arbeitsweise - Hervorragende Kommunikationsfähigkeiten mit einer teamorientierten Einstellung - Leidenschaft für digitale Gesundheitslösungen - Hohes Engagement, ausgeprägte emotionale Intelligenz und Anpassungsfähigkeit an ein dynamisches Arbeitsumfeld Benefits - Eine sinnstiftende Tätigkeit an der Schnittstelle von Medizin, Forschung und digitaler Versorgung - Mitarbeit an Evaluationsstudien für digitale Gesundheitsanwendungen mit realem Versorgungskontext - Ein interdisziplinäres, engagiertes Team mit medizinischer, wissenschaftlicher und digitaler Expertise - Flexible Zusammenarbeit in Teilzeit - Remote-Arbeit innerhalb Deutschlands oder Zusammenarbeit am Standort Hamburg - Eine projektbefristete Tätigkeit für ca. 4–6 Monate - Die Möglichkeit, aktiv zur Weiterentwicklung evidenzbasierter digitaler Gesundheitsversorgung beizutragen Contact Information Frau Jeanine Metaschk

Title: FFS Clinical Supervisor Location: Bronx NY Job Description: Ready for a summer schedule that works for you? Summer Fun Fridays at Northeast Family Services! We close at 12:30pm every Friday from Memorial Day through Labor Day — giving our team more time to relax, recharge, and enjoy the summer sunshine! Northeast Family Services is a premier mental health provider with over 20 years of experience providing services to children, youth, and families. Are you excited to join an agency with a long-standing history of providing high quality care? Well, we are excited to meet YOU! We are seeking an experienced clinician (LCSW) with supervisory experience to join our growing New York team as a Fee-For-Service Clinical Supervisor! The Fee-For-Service Clinical Supervisor will provide clinical and administrative supervision for our Home and Community Based services staff who provide structured, consistent, strength-based therapeutic interventions in a client’s home for the purpose of treating a youth’s behavioral health needs. We utilize multiple evidence-based practices that promote a family’s strengths! The Clinical Supervisor will be responsible for managing the direct care of staff, as well as overseeing the content and implementation of in-home treatment plans. The Fee-For-Service Clinical Supervisor will also carry a small caseload. If you're looking to make a change, don't miss this career opportunity to join a growing and supportive community organization that truly cares about their clients! Hybrid work schedule available Language Differential provided for Spanish, Chinese, Korean, Russian and Hindi! Qualifications: - Master's degree in social work - LCSW - Independent NY state licensure is required for this role - Minimum 2 years of experience supervising clinicians who work with children, youth, adolescents, and families in a home or community setting - Proficient with supervision, service delivery and case management fundamentals - Experience in quality management preferred - Excellent written and verbal communication skills - Proficiency with computers, including Microsoft Office - Valid driver’s license with access to a reliable vehicle preferred - Access to a laptop or CPS, secure internet, and a phone required. - Applicants must be authorized to work in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. Essential Functions: - Completing Intake Assessments - Supporting new staff through the orientation process by modeling and coaching - Completing and reviewing Treatment Plans within the Electronic Health Record - Providing weekly clinical and task supervision to staff team members - Modeling the process of opening new cases including initial home visit - Carry a small caseload of at least 10 hours per week Compensation: - $62 -$70 / Hour