Site Manager-Indianapolis, IN
Company: Care Access
Location: Indianapolis
Posted on: May 2, 2024
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Job Description:
What We DoCare 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 AreWe 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.Position OverviewThe 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 OnDuties 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 qualityTherapeutic
Responsibilities: 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 ResearchStudy Preparation: 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-inclusiveWhat You BringRole Requirements: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 supervisionCertifications/Licenses, Education, and
Experience: RN or LPN/LVN preferred Research Professional
Certification- CRCC preferred Bachelors 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
requiredBenefits (US Full-Time Employees 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 planDiversity & InclusionWe 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. Were 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. Were
proud to advance these breakthroughs and work with the big players
while engaging with the bestphysicians 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.Employment StatementCare Access complies with all employment
laws and regulations with respect to its employment practices,
terms and conditions of employment, and pay equity and wages. Care
Access does not engage in any unfair or forced labor practice and
does not tolerate, under any circumstances, the use of any form of
forced or involuntary labor, child labor, or human trafficking.
This extends to suppliers, partners, or other third parties with
whom Care Access does business. Care Access values and promotes the
protection of human rights everywhere.by Jobble
Keywords: Care Access, Bloomington , Site Manager-Indianapolis, IN, Executive , Indianapolis, Indiana
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