Source Job

• Maintain a working knowledge of Protocol Coordinator responsibilities and work instructions.
• Provide quality control reviews on protocols, informed consent documents (ICDs), and supplemental documents across Leagues, as assigned.
• Serve as the subject matter expert in the creation of Informed Consent Forms and Therapy Delivery Maps consistent with the organization’s standards.

COG Research Foundation, LLC is the federal grantee organization for the Children's Oncology Group (COG). The COG unites over 12,000 experts in childhood cancer at more than 220 leading children’s hospitals, universities, and cancer centers across the United States, Canada, Australia, New Zealand, and Saudi Arabia.

• Independently coordinates assigned study activities in accordance with study protocols, SOPs, and applicable regulatory requirements.
• Screens potential research participants for eligibility, documents inclusion/exclusion determinations, and escalates complex eligibility questions as needed.
• Manages scheduling and execution of virtual and home-based study visits, assessments, and follow-up activities with minimal supervision.

Synapticure provides instant access to expert neurologists, cutting-edge treatments and trials, and wraparound care coordination and behavioral health support in all 50 states through a virtual care platform. Partnering with providers and health plans, including CMS' new GUIDE dementia care model, Synapticure is dedicated to transforming the lives of millions of individuals and their families living with neurodegenerative diseases like Alzheimer’s, Parkinson’s, and ALS.

• Responsible for managing research activities at sites participating in Worldwide’s clinical research projects.
• Involved in all stages of the clinical study, including identifying potential sites and performing study start-up activities.
• Conduct study initiation visits and ensure compliance with informed consent and reporting potential safety events.

Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries, innovates and invents to cure the world’s most persistent diseases. They are a global team of over 3,500+ experts, bright thinkers, dreamers and doers that are changing the way the world experiences CROs.

• Assist in contacting investigator sites to provide study specific information.
• Ensure receipt, completeness and accuracy of clinical and administrative documents.
• Coordinate distribution and shipment of study-related materials.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient.

• Manages the financial, regulatory, patient management, and human resources functions associated with conducting clinical trials.
• Supervises a staff of 2 - 5 employees; trains new clinical trials staff; tracks enrollment, sponsor payments, and salary.
• Provides leadership in business development and assists residents in preparing research projects by facilitating IRB submissions and protocol writing.

Emory University is a leading research university fostering excellence and attracting world-class talent to innovate today and prepare leaders for the future. They welcome candidates who can contribute to the excellence of their academic community.

• Conduct research to understand healthcare needs and identify ways to reach caregivers.
• Perform telephonic outreach to enroll children in care and ensure onboarding.
• Collaborate with healthcare professionals to support patient re-engagement.

Imagine Pediatrics is a tech-enabled, pediatrician-led medical group reimagining care for children with special health care needs. They deliver 24/7 virtual-first and in-home medical, behavioral, and social care, working alongside families, providers, and health plans.

• Responsible for an appeals caseload.
• Responsible for the Care Coordination staff for case reviews and UR appeals.
• Coordinates worklists and completion of cases on audit review, retro authorization and appeals.

Northside Hospital is an award-winning and state-of-the-art healthcare provider that is constantly growing. They are expanding the quality and reach of their care to patients and communities, creating more opportunity for healthcare professionals in Atlanta and beyond.

• Maintain project documentation including presentations, plans, agendas and overall project timelines.
• Act as the primary liaison between technical teams and external partners to ensure alignment on project goals.
• Provide proactive communication by setting clear expectations and providing project updates before client requests.

Medrio seeks smart and capable individuals to expand product capabilities, grow their business, and better serve customers. They value collaboration, ingenuity and creating a culture of excellence, offer great benefits and promote an atmosphere of work/life balance, including flexible work schedules and locations.

• Collaborates with members, family, and healthcare providers to coordinate services and address barriers.
• Guides members to achieve optimal health by providing tools and information to understand their healthcare options.
• Identifies and assesses members’ medical, behavioral, social, emotional, and financial needs.

Capital Blue Cross promises to go the extra mile for their team and community. They are one of the “Best Places to Work in PA”, with a caring and supportive culture that values professional and personal growth through training and continuing education.

• Considered as the primary point of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
• Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs).
• Customize site engagement strategy for assigned study (ies) under supervision. Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.

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. They strive to have a remarkable impact on people's lives across several key therapeutic areas. For more information about AbbVie, please visit them at www.abbvie.com.

• Maintain full ownership and accountability for initiating phone contact to potential study participants.
• Conduct phone-based pre-screening interviews for potential study participants to determine pre-qualification status.
• Consistently provide outstanding customer service with every patient interaction.

M3 Wake Research is an integrated network of premier investigational sites meeting clinical research needs. They have close to 30 owned and managed research sites across the country and continue to grow through acquisitions.

• Establish and maintain contact with assigned oncology members via phone, text, email, and video calls.
• Initiate nursing care plans, educating members on treatment regimens, symptom management, side effects, and disease-specific program benefits.
• Obtain and use clinical information to develop individualized member and clinician-centered care plans that complement oncologist guidance/plan of care.

Renalogic is dedicated to helping clients manage the human and financial costs of chronic kidney disease. They hire people who are humble, hungry, and smart, and their 96% client retention suggests they’re on the right path.

• Establishes and maintains a document management system for regulatory electronic files.
• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
• Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.

Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.

• Provide administrative and programmatic support for a VA Research Office
• Process research proposals involving the use of animal subjects and the use of hazardous biological or chemicals in medical research
• Support the Research Office to conduct audits of regulatory documents

Aptive Resources partners with federal agencies to achieve their missions through improved performance, streamlined operations, and enhanced service delivery. Founded in 2012, they have 300+ employees nationwide and specialize in applying technology, creativity and human-centered services.

• Provide strategic and administrative leadership for clinical research business and operational activities.
• Ensure studies are conducted in accordance with regulatory requirements and sponsor expectations.
• Drive operational performance, program growth, and team development across the clinical research enterprise.

Florida Cancer Specialists & Research Institute (FCS) has built a national reputation for excellence since 1984. With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations, they utilize innovative clinical research, cutting-edge technologies, and advanced treatments.

• Provide administrative and programmatic support for research and program offices.
• Support various research committees and initiatives, which may include the Subcommittee on Research Safety (SRS), the Institutional Animal Care and Use Committee (IACUC), and the Research and Development (R&D) Committee.
• Process research proposals involving the use of animal subjects and/or hazardous biological or chemical materials in medical research, including receipt, logging, routing, tracking, inquiry, evaluation, review, action and response.

Aptive Resources partners with federal agencies to achieve their missions through improved performance, streamlined operations and enhanced service delivery. It was founded in 2012 and has 300+ employees nationwide, specializing in technology, creativity and human-centered services.

• Conduct timely reviews of clinical trials relying on external IRBs or where Cooper serves as the reviewing IRB.
• Ensure research upholds ethical standards, complies with SOPs, and supports clinical trial start-up.
• Execute reliance agreements with support from the HRPP Director and Legal, when applicable.

Cooper University Health Care is committed to providing extraordinary health care. They are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols.

• Maintain and execute the NCI annual TTA plan, track training events and webinars.
• Manage workflows for individualized coalition TA, including intake and tracking.
• Oversee the production and quality review of training materials.

Synergy Enterprises, Inc., is a minority- and woman-owned government contractor located in North Bethesda, MD. They are committed to delivering the highest quality services with integrity and responsiveness.

• Assist Clinical Project Manager in the development and management of company-sponsored global clinical trials.
• Provide support in site recruitment, site initiation, site payments and site close-out.
• Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.

ImmunityBio, Inc. is a commercial-stage biotechnology company that develops cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system. The company is publicly traded with headquarters in Southern California, offering a collaborative environment with professional development opportunities.

• Monitor and own the progress of clinical studies at investigative sites.
• Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
• Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. They have a strong focus on Oncology and Rare Disease and passionate about cultivating their culture with high CRA retention rates.