- Ability to understand and follow institutional SOPs.
- Review and assess protocol (including amendments) for clarity, logistical feasibility
- Ensure that all training and study requirements are met prior to trial conduct.
- Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
- Assist with planning and creation of appropriate recruitment materials.
- Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
- Actively work with recruitment team in calling and recruiting subjects
- Attend Investigator meetings as required.
- Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
- Assist in the creation and review of source documents.
- Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
- 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.
- 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)
- 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.
- This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role.
- Excellent working knowledge of medical and research terminology
- Excellent working knowledge of federal regulations, good clinical practices (GCP)
- Ability to communicate and work effectively with a diverse team of professionals.
- Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
- Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
- Critical thinker and problem solver
- Friendly, outgoing personality; 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.
- Bachelor's Degree preferred, or equivalent combination of education, training and experience.
- A minimum of 3 years prior Clinical Research Coordinator experience required
- Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
- Recent phlebotomy experience required
- 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
-
Research Coordinator
3 weeks ago
RadNet Thousand Oaks, United StatesResponsibilities · Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, we are Radiology Forward. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of our success is its people with ...
-
Research Coordinator
3 weeks ago
RadNet Thousand Oaks, United StatesResponsibilities · Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, we are Radiology Forward. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of our success is its people with ...
-
Research Coordinator
4 weeks ago
RadNet Ventura (Rolling Oaks Radiology) Westlake Village, United StatesJob Description: · Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, we are Radiology Forward. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of our success is its people wit ...
-
Clinical Research Coordinator
3 weeks ago
Care Access Thousand Oaks, United StatesWhat 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 accele ...
-
UCLA Health Westlake Village, United StatesGeneral Information · Press space or enter keys to toggle section visibility · Work Location: Westlake Village, USA · Onsite or Remote · Fixed Hybrid · Work Schedule · Monday - Friday, 8:00am - 5:00pm · Posted Date · 02/14/2024 · Salary Range: $ Hourly · Employment Type · 2 - Sta ...
-
UCLA Health Westlake Village, United StatesGeneral Information · Press space or enter keys to toggle section visibility · Work Location: Westlake Village, USA · Onsite or Remote · Fixed Hybrid · Work Schedule · Monday - Friday, 8:00am - 5:00pm · Posted Date · 02/14/2024 · Salary Range: $ Hourly · Employment Type · 2 - Sta ...
-
UCLA Health Westlake Village, United StatesJOB DUTIES · Description The Clinical Research Coordinator contributes to the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. In this role, you will be responsible for the implementation of research acti ...
-
Competitive Intelligence Manager, Gen
3 weeks ago
Amgen Thousand Oaks, United States**HOW MIGHT YOU DEFY IMAGINATION?** · You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients ...
-
Operations Analyst
3 weeks ago
SEI1GLOBAL Oaks, United StatesAs a member of the SEI Wealth Platform, US Operations, the Corporate Actions Analyst role requires a self-motivated, goal-oriented individual to work in a team environment, manage multiple tasks in a time-sensitive delivery schedule. The Corporate Actions team proactively researc ...
-
Amgen Thousand Oaks, United States**HOW MIGHT YOU DEFY IMAGINATION?** · You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients ...
-
Talent Development Manager
3 weeks ago
Sage Thousand Oaks, United StatesThe Talent Development Manager builds strong partnerships with stakeholders throughout the company and works to improve organizational effectiveness, facilitate learning and change, coach high-performing employees, contribute to the success of Sage's ongoing DEI efforts, and incr ...
-
Operations Analyst
2 weeks ago
SEI1GLOBAL Oaks, United StatesThe Corrections and Reversals Analyst works in SEI Private Trust Company, a wholly owned subsidiary of SEI. This role requires a self-motivated, goal-oriented individual with the ability to manage multiple tasks in a time sensitive delivery schedule. The Corrections and Reversals ...
-
Operations Analyst
1 week ago
SEI1GLOBAL Oaks, United StatesAs a member of the SEI Wealth Platform, US Operations, the Trade Settlement analyst role requires a self-motivated, goal-oriented individual to work in a team environment, manage multiple tasks in a time-sensitive delivery schedule. The Trade Settlement team monitors and processe ...
-
Regulatory Policy and Intelligence Director
3 weeks ago
Amgen Thousand Oaks, United States**HOW MIGHT YOU DEFY IMAGINATION?** · If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collabor ...
-
Operations Analyst
3 weeks ago
SEI1GLOBAL Oaks, United StatesAs a member of the Free Asset Movement team, the Free Asset Movement Analyst role requires a self-motivated, goal-oriented individual to work in a team environment, manage multiple tasks in a time-sensitive delivery schedule. The Free Asset Movement team is tasked with the satisf ...
-
Business Operations Manager
2 weeks ago
The Wisdom Center Thousand Oaks, United States**MAKE A DIFFERENCE** · **Company Overview**: · The Wisdom Center is the leading provider of Adult Day Services and Enhanced Care Management Programs on the Central Coast. Setting the standard for Enhanced Care Management and targeted CalAim Community Support programs throughout ...
-
Virtual Office Admin
3 weeks ago
Kramer-Wilson Co of Delaware Inc Westlake Village, United StatesOFFICE ADMIN · **Primary Function**: · The Virtual Office Admin will assist with general office activities as determined and directed by the Office Manager(s). The Office Admin will be responsible for assisting the staff with general office duties including, but not limited to, r ...
-
Drug and Alcohol Counselor
1 week ago
Clean Treatment Center Westlake Village, United StatesResponsibilities: · - Provide counseling services to individuals, families, and groups · - Conduct assessments and develop treatment plans based on client needs · - Utilize various therapeutic techniques, including cognitive behavioral therapy and behavior management strategies · ...
-
Clinical Research Coordinator
3 weeks ago
Om Research LLC Camarillo, United StatesThe Assistant Clinical Research Coordinator comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal regulations. Some responsibilities of the Assistant Clinical Research Coordinator include: ...
-
Front Desk Administrative Assistant
1 week ago
ZS Thousand Oaks, United States: · **ZS** is a place where passion changes lives. As a management consulting and technology firm focused on transforming global healthcare and beyond, our most valuable asset is our people. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping ...
Clinical Research Coordinator - Thousand Oaks, United States - Care Access
Description
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%.
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.
Position Overview
The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
Duties include but not limited to:
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 RequirementsKnowledge, Skills, and Abilities:
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 thephysicians and caring for patients.
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.
Employment Statement
Care 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.