Location: Dorchester, MA
Employment Type: Full-time Employment
Team: Site Operations
What We Do
Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
The Site Manager is responsible for the most pivotal and complex protocols and study designs being conducted at Care Access Research sites.
What You'll Be Working On
Duties include but not limited to:
Site Support Responsibilities:
· Supports Key Sponsors and CROs
· Manages some of the sites most challenging therapeutic areas and study designs
· Able to monitor and mentor all levels of CRCs to ensure complete understanding of Care Access Research processes, SOPs and values, ensuring that a successful transition to more demanding opportunities and responsibilities
· Assist Region Manager
· Assist Region Manager in performing quality control check of all study source documents for completeness and quality
· Demonstrate deep knowledge about the therapeutic area of responsibility
· Demonstrate comprehensive understanding of related Protocol designs, outcomes and timelines
· Engage in continuous independent learning within the therapeutic area of responsibility
· Act as a primary point of contact in the therapeutic field for Care Access Research
· Study Management:
· Prioritize activities with specific regard to protocol timelines
· Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
· Maintain effective relationships with study participants and other care Access Research personnel.
· Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
· Communicate clearly verbally and in writing.
· Patient Coordination:
· Prescreen study candidates
· Obtain informed consent per Care Access Research SOP .
· Complete visit procedures in accordance with protocol.
· Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
· Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
· Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
· Documentation :
· Record data legibly and enter in real time on paper or e-source documents
· Accurately record study medication inventory, medication dispensation, and patient compliance.
· Resolve data management queries and correct source data within sponsor provided timelines
· Assist regulatory personnel with completion and filing of regulatory documents.
· Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
· Physical and Travel Requirements
· This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
What You Bring
Knowledge, Skills and Abilities:
· Excellent working knowledge of medical and research terminology
· Excellent working knowledge of federal regulations, good clinical practices (GCP)
· Understanding of issues affecting clinical research in the identified therapeutic area of expertise
· Ability and willingness to mentor and guide less experienced CRC as they develop and gain experience in all therapeutic areas
· Ability to communicate and work effectively with a diverse team of professionals
· Excellent organizational, prioritization and leadership skills and capabilities with a strong attention to detail
· Excellent computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel
· Critical thinker and problem solver
· Excellent interpersonal skills, detailed oriented and meticulous
· Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
· High level of self-motivation and energy
· Excellent professional writing and communication skills
· Ability to work independently in a fast-paced environment with minimal supervision
Certifications/Licenses, Education, and Experience:
· RN or LPN/LVN preferred
· Research Professional Certification- CRCC preferred
· Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
· A minimum of 5 years experience as a Clinical Research Coordinator requied
· Prefer1 year of experience as a Care Access Research Clinical Research Coordinator
· Recent phlebotomy experience required
Benefits (US Full-Time Emplo yees Only)
· PTO/vacation days, sick days, holidays.
· 100% paid medical, dental, and vision Insurance. 75% for dependents.
· HSA plan
· Short-term disability, long-term disability, and life Insurance.
· Culture of growth and equality
· 401k retirement plan
Diversi ty & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.
At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best
physicians and caring for patients. Our team of experts is paving the way to take this vision forward through innovation and a unique technology-enabled.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access currently is unable to sponsor work visas.