Senior Clinical Research Associate
Location
Massachusetts
Posted
92 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Senior Clinical Research Associate
AbbVie
Title: Senior Clinical Research Associate Location: Boston, MA, United States Remote Full-time Salary Min: 94000 Salary Max: 178500 Workday Global Grade: 17 Compensation: USD 94,000 - USD 178,500 - yearly Job Description: Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience. Responsibilities: Considered as the Primary Sponsor Point of contact for the investigative site. Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning. Ability to motivate and align monitoring community through leadership and mentorship. - Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. Able to support, guide, and mentor junior personnel on Site Management activities. - Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects. - Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy. - Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Expert understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape/patient journey to enable successful patient recruitment and overall protocol compliance. - Possesses advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. Supports local onboarding of more junior CRAs. Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes. - May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager. - Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer-centric approach. - Independently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators. - Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable. - This is a remote position. Candidates must be based in MA and be willing to travel for site visits. Qualifications - Education: Bachelor's degree or equivalent degree; health-related preferred (e.g. Medical, Scientific, Nursing, Pharmacy). - Minimum of 3 years of clinically related experience, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoring. - Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials - Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. - Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders. - Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. - Superior ability to leverage technology, tools and resources to provide customer-centric support based on the health of the site. - Superior interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training. - Ability to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues - Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: - The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. - We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. - This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, https://www.abbvie.com/join-us/reasonable-accommodations.html
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Medical Dosimetrist - Pediatric Research Support
Mass General BrighamMass General Brigham connects a full spectrum of care across a system of academic medical centers, specialty and community hospitals, physician networks, a heal
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Starting pay rate $130k The Mass General Brigham Cancer Institute’s Department of Radiation Oncology is a leader in developing and implementing some of the most innovative and effective radiation therapies in the world. Massachusetts General Hospital and Brigham and Women’s Hospital, founding members of Mass General Brigham, are ranked by U.S. News & World Report as two of the nation’s best hospitals and work together as one team to deliver extraordinary care. Become a member of our department as a Medical Dosimetrist supporting Pediatric Cancer research as part of a collaboration with M3 Pediatric Cancer Registry! M3 (Multi-institutional, Multi-disciplinary, and Multi-omic) Pediatric Cancer Registry: the M3 Collaboration is a comprehensive multi-institutional pediatric cancer and tumor registry that will use AI-augmented and automated procedures to capture multidimensional patient data in pediatric cancer patients to accelerate research and improve disease control and quality of survivorship. Data collection will include treatment exposures (inclusive of radiation treatment plans, surgery, chemotherapies), biologic characteristics of the tumor and patient, and outcomes measures with the purpose of improving cures and quality of survival. This is a merging of efforts from the Pediatric Proton/photon Consortium Registry (PPCR, 26 centers, Massachusetts General Hospital (MGH) lead), the Childhood Brain Tumor Network (CBTN, 37 centers with Children’s Hospital of Pennsylvania lead) and Johns Hopkins Radiation and Advanced Analytics Program. This is funded by a philanthropic grant from an anonymous donor. We look forward to welcoming a new teammate to help support and oversee storage and quality control of pediatric radiation treatment plans for the M3 Collaboration. Most work will be accomplished remotely except for being on site at MGH for onboarding and to institutional sites as needed to assist in development of export methodologies and workflows for image and radiation plan transfers. Competitive Compensation and Benefits Packages including: • Starting pay of $130k annually • Comprehensive Medical, Dental and Vision insurance • Tuition Reimbursement • Paid Parental Leave • Resources for childcare and emergency backup care • Hospital-paid retirement plan and tax-sheltered annuity plan • Subsidized Massachusetts Bay Transportation Authority (MBTA) passes • Employee perks - enjoy discounts on tickets and passes for everything from ski resorts to museums to sporting events. Job Summary Manage and oversee storage and quality control of radiation treatment plans using the MiM software for the M3 Collaboration. Interface with participating institution’s dosimetry and physics teams to facilitate radiation plan and diagnostic imaging transfers while serving as primary contact for MiM personnel and other dosimetry teams under the M3 Collaboration. Develop and perform treatment plan quality control procedures within MiM to monitor treatment planning data sent from participating sites. Identify and contour normal and dose-limiting structures using AI-supported tools in MiM by utilizing images from one or more data sets. Utilize scripting and workflows in MiM for creation of composite plans and data quality control and extraction. Meet weekly with research teams and researchers from a variety of disciplines and backgrounds towards fulfillment of M3 Collaboration’s aspirations. Maintain and enhance knowledge of both proton and photon (3DCRT, IMRT, VMAT, SBRT) treatment planning techniques, delivery, and software with a specific focus for pediatric patients. Participate in continuing education and quality improvement processes in support of this knowledge development. Aid in orientation and education activities for members of the M3 Collaboration as needed. Qualifications Education Bachelor’s degree in physics (or a related Life, Physical, or Applied Science) is required. JRCERT-accredited Formal Education in Medical Dosimetry (BS/MS/Certificate) is preferred. Can this role accept experience in lieu of a degree? No Licenses and Credentials Medical Dosimetrist Certification Board (MDCB) eligibility is required, while MDCB certification is preferred. 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Tools include computers as well as clinical guidelines, current medical terminology, information, and communication systems. - Possess good communication and interpersonal skills to facilitate the exchange of information with all research members of the M3 Collaboration, including doctors, registered nurses, data engineers, bioinformaticians, biostatisticians, clinical research coordinators, and program and project managers. - Has high level critical thinking and problem-solving skills and can work both independently and in collaboration with other professionals. - Willingness to work on related items to forward the mission of the M3 Additional Job Details (if applicable) Physical Requirements - Standing Frequently (34-66%) - Walking Frequently (34-66%) - Sitting Occasionally (3-33%) - Lifting Frequently (34-66%) 35lbs+ (w/assisted device) - Carrying Frequently (34-66%) 20lbs - 35lbs - Pushing Occasionally (3-33%) - Pulling Occasionally (3-33%) - Climbing Rarely (Less than 2%) - Balancing Frequently (34-66%) - Stooping Occasionally (3-33%) - Kneeling Occasionally (3-33%) - Crouching Occasionally (3-33%) - Crawling Rarely (Less than 2%) - Reaching Frequently (34-66%) - Gross Manipulation (Handling) Frequently (34-66%) - Fine Manipulation (Fingering) Frequently (34-66%) - Feeling Constantly (67-100%) - Foot Use Rarely (Less than 2%) - Vision - Far Constantly (67-100%) - Vision - Near Constantly (67-100%) - Talking Constantly (67-100%) - Hearing Constantly (67-100%) Remote Type Remote Work Location 45 Fruit Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $118,435.20 - $172,234.40/Annual Grade 8 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
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