Location: Alabaster, Alabama
Company: Syneos Health
practical value to help our customers achieve their objectives. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across
110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able
to create a place where everyone feels like they belong. Job responsibilities Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. backsses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): backsses site processes Conducts Source Document Review of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture Verifies site compliance with electronic data capture requirements May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr.
CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include: Site support throughout the study lifecycle from site identification through close out Knowledge of local requirements for real world late phase study designs Chart abstraction activities and data collection As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff Identify and communicate out of scope activities to Lead CRA/Project Manager Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations Identify operational efficiencies and process improvements Develop country level informed consent forms Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared Participate in bid defense meetings Qualifications What we're looking for Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills.
Basic level of critical thinking skills expected. Ability to manage required travel of up to 75% on a regular basis Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. #LI-RR1PDN-993157aa-c4d2-4a08-b159-23c531aba44b
more flexible hours. And working at Gainwell carries its rewards. You’ll have an incredible opportunity to grow your career in a company that values work-life balance, continuous learning, and career development. Summary We are seeking a talented individual for a Manger of Clinical Review to provide leadership and management for our clinical claim review teams which include: Utilization Management, Utilization Review, Prior Authorization, Coding and DRG Validation to ensure that contract goals are achieved and quality of service is maintained.
Your role in our mission Oversees clinical claim review activities for assigned accounts to maximize team performance, meet or exceed contractual
obligations, and deliver customer satisfaction consistent with established operating policies and procedures. Continually works to improve efficiency, productivity, quality, and reduce operational costs.
Works with the Medical Director and Clinical Policy team, to develop internal review guidelines, clinical review processes and procedures to ensure compliance with client deliverables while maintaining high quality and performance standards across all contracts. In coordination with the Quality Management Committee, develops and maintains quality policies and standards to ensure compliance with Utilization Review Accreditation Committee (URAC) accreditation requirements. Serves as the
SME in evaluating new business opportunities, responding to requests for proposal, and implementing new clients or products.
What we’re looking for Bachelor’s degree in Nursing, Healthcare Administration, Business Administration, or related field required 10+ year’s healthcare/insurance experience with increasing responsibility required 3+ year’s management or supervisory experience required What you should expect in this role Remote (Work from Home) In order to effectively work as a remote worker (work from home) with Gainwell, employees Broadband Internet connections, should have a minimum speed of 24 MBS download and 8 MBS upload. Greater speeds will of course provide better performance.
To Test your internet download and upload speed: Go to Google. Search for Internet Speed Test or click here. Up to 20% Travel Video cameras must be used during all interviews, as well as during the initial week of orientation if hired. #LI-NB1 #LI-REMOTE The pay range for this position is $82,700.00 - $118,100.00 per year, however, the base pay offered may vary depending on geographic region, internal equity, job-related knowledge, skills, and experience among other factors. Put your passion to work at Gainwell. You’ll have the opportunity to grow your career in a company that values work flexibility, learning, and career development.
All salaried, full-time candidates are eligible for our generous, flexible vacation policy, a 401(k) employer match, comprehensive health benefits , and educational assistance. We also have a variety of leadership and technical development academies to help build your skills and capabilities. We believe nothing is impossible when you bring together people who care deeply about making healthcare work better for everyone. Build your career with Gainwell, an industry leader. You’ll be joining a company where collaboration, innovation, and inclusion fuel our growth.
Learn more about Gainwell at our company website and visit our Careers site for all available job role openings. Gainwell Technologies is committed to a diverse, equitable, and inclusive workplace. We are proud to be an Equal Opportunity Employer, where all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical condition), interactionual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
We celebrate diversity and are dedicated to creating an inclusive environment for all employees. For more details: jobs-search. org/marketing_tennessee-r782084/manager-clinical-review-work-from-home-united-states_i1978412617
progress, as well as write novel conversations in order to teach them what to say. Benefits: ● This is a full-time or part-time REMOTE position● You’ll be able to choose which projects you want to work on● You can work on your own schedule● Projects are paid hourly, starting at $20 USD per hour, with bonuses for high-quality and high-volume work Responsibilities: ● Come up with diverse conversations over a range of topics● Write high-quality answers when given specific prompts● Compare the performance of different AI models● Research and fact-check AI responses Qualifications: ● Fluent in English● A bachelor's degree (completed or in progress)● Excellent writing and grammar skills● Strong research
and fact-checking skills to ensure accuracy and originality● Previous experience as a Freelance Writer, Content Writer, Editor, Copywriter, Copy Editor, or those with experience in journalism and/or media is preferred but not required Note: Data Annotation payment is made via Pay Pal.
We will never ask for any money from you. Pay Pal will handle any currency conversions from USD. If you are applying from any country outside of the US, Canada, the UK, Ireland, Australia, or New Zealand and sign up, please note that you will NOT receive a link as we are NOT taking applicants outside of those countries at this time. If you are applying from within those countries, it is possible to experience
a 2 week delay, as we are currently receiving a significant number of applications, and work and pay can fluctuate based on project availability and the skillsets found in the backssment.
Additional information: Salary: 20 Frequency: Per hour Employment type: Full-time For more details: jobs-search. org/other-jobs_mississippi-r782066/job_i1979123686
