We are seeking a Clinical Research Specialist I to join our team in a 100% remote capacity. This role requires experience as a Research Specialist in clinical trials. The position is fully remote; however, candidates must reside in an approved state. Work hours are Monday through Friday, either 9:00 AM - 5:30 PM or 8:00 AM - 4:30 PM. The Clinical Research Specialist I provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. 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) and local Institutional Review Board (IRB). Primary Duties and Responsibilities - 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. - Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees. - 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) and local Institutional Review Board. - Maintains research practices using Good Clinical Practice (GCP) guidelines. - Maintains strict patient confidentiality according to HIPAA regulations and applicable law. - Participates in required training and education programs.

Description ATTENTION! $5,000 SIGN-ON BONUS! Gateway Rehab is searching for a home-based Coordinator who is responsible for pre-admission level of care assessment and case management of patients. This position is remote, but the ideal candidate must live in the Pittsburgh, PA region. This position receives infrequent supervision and instruction. Available shifts are 5 days 8 hours OR 4 days 10 hours with consisting of evenings and weekends coverage. Responsibilities - Acts as an initial point of contact to potential patients and referral sources. - Offers support to family members, potential patients and referral sources. - Completes clinical assessments to help determine level of care based on ASAM criteria. - Uses motivational interviewing skills to further complete evaluation. - Consults with management as needed to determine medical and/or psychiatric appropriateness. - Uses DSM-5 guidelines for diagnostic criteria. - Coordinates admissions to inpatient treatment between various locations by communicating with multiple departments. - Coordinates transfers from satellite sites and/or other facilities (such as hospitals, jails, and other D&A providers). - Schedules outpatient evaluations as needed. - Completes initial inpatient precertification requests with funding sources and ensures all needed documentation is complete. - Completes peer to peer reviews as needed. - Acts as a liaison with UR staff and enters authorization information into patient database. - Acts as a resource to staff regarding county funded, managed care, and commercial insurance procedures. - Responds to and provides case management services to referral sources. Knowledge, Skills, and Abilities - Computer proficiency with working knowledge of Word, Excel, and use of e-mail. - Excellent verbal and written communication skills and organizational skills. - Familiarity with drug and alcohol/mental health treatment and/or managed care processes required. - General understanding of ASAM criteria. - Ability to multi-task - Excellent time management skills Requirements - Bachelor’s Degree. - Experience conducting assessments and evaluations. Preferred Requirements - Master’s Degree and/or Registered Nurse with current PA licensure Additional Requirements: - Pass PA Criminal Background Check. - Obtain Child Abuse and FBI Fingerprinting Clearances. - Pass Drug Screen. - 2-Step TB Test. Work Conditions - Evenings and weekends as needed - Home-based - Minimal physical demands - Significant mental demands include those associated with working with patients with addictive disorders and managing multiple tasks. GRC is an Equal Opportunity Employer committed to diversity, equity, inclusion, and belonging. We value diverse voices and lived experiences that strengthen our mission and impact.

Labcorp is a global leader in diagnostic testing and drug development solutions, helping healthcare providers, researchers, and patients make informed decisions that advance care. Join us in our mission to improve health and improve lives. Labcorp is seeking a US based remote Senior Clinical Research Associate to join our team! Job Responsibilities: The Labcorp Clinical Affairs Senior Clinical Research Associate (SCRA) plays a pivotal role within our organization. The SCRA ensures the successful planning, coordination, and execution of clinical trials, fundamentally contributing to groundbreaking advancements in laboratory diagnostics and patient care. This role is essential in verifying that clinical trials are conducted in adherence to stringent regulatory standards, Good Clinical Practice (GCP) guidelines, and ethical norms. SCRA’s are tasked with a wide variety of responsibilities, ranging from overseeing trial sites and ensuring data integrity to liaising with cross-functional teams and ensuring subject safety. The ideal candidate will possess a robust blend of scientific knowledge, meticulous attention to detail, and exceptional organizational and communication skills Minimum Qualifications: - Bachelor’s degree - 5 or more years of experience as a Clinical Research Associate - 3 or more years of experience with electronic data capture (EDC) systems - 3 or more years of experience with Microsoft Office Suite Additional Job Standards: - Ability to effectively understand and interpret regulatory requirements and guidelines - Ability to effectively communicate both verbal and written skills with study sites and team members - Ability to be organized and have attention to detail - Ability to work independently and manage multiple tasks with minimal oversight - Ability to effectively analyze and solve problems - Ability to travel for on-site monitoring visits - Ability to prioritize workload for self and team Application window through: 04/22/2026 Pay Range: $115k - $140k - annually (USD) All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO. For more detailed information, please click here.  Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

This is what you will do: The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The Sr. CRA works in close collaboration with (Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA) and other CRAs in Country Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level. The Sr. CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery and compliance of the study. The Sr. CRA is responsible for the selection, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. A Sr. CRA with demonstrated skillset and experience may take on additional responsibilities and tasks as needed (eg. Lead CRA, etc). You will be responsible for: - Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP). - Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalate them as appropriate. - Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles. - Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and mitigation plans. - Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.) - Preparing and finalizing monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with Alexion SOPs. - Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs and local requirements. Supporting/participating in regular QC checks of the eTMF - In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. - Contributing to the nomination and selection of potential investigators and assisting with feasibility activities - Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP) and other internal stakeholders, as needed. - Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to PMCO, Director COM, HCO and/or Quality Group as required. - Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with PMCO, Director COM, and Quality Group. You will need to have: - Minimum of 4 years of CRA monitoring experience - Bachelors degree in related discipline, preferably in life science, or equivalent qualification - Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Excellent knowledge of relevant local regulations. - Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas. - Good understanding of the drug development process. - Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management. - Excellent attention to detail. - Excellent written and verbal communication skills. - Excellent collaboration and interpersonal skills. - Good negotiation skills. - Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods) - Valid driving license We would prefer for you to have: - Ability to work in an environment of remote collaborators and in a matrix reporting structure - Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. - Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. - Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. - Proactivity and assertive when communicating with internal stakeholders and sites - Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. - Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. - Experience in all study phases and in rare medical conditions preferred. Date Posted 20-Apr-2026 Closing Date 10-May-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.