Clinical Research Coordinator II
- [job_card.full_time]
About Care Access
Care Access is working to make the future of health better for all.With hundreds of research locations mobile clinics and clinicians across the globe we bring world-class research and health services directly to communities that often face barriers to care.We are dedicated to ensuring that every person has the opportunity to understand their health access the care they needand contribute to the medical breakthroughs of tomorrow.
With programs likeFuture of Medicine which makes advanced health screenings and research opportunities accessible to communities worldwide andDifference Makers which supports local leaders to expand their community health and wellbeing efforts we put people at the heart of medical progress. Through partnerships technology and perseverance we are reimagining how clinical research and health services reach the world. Together we are building a future of health that is better and more accessible for all.
To learn more about Care Access .
How This Role Makes a Difference
The Clinical Research Coordinators 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.
How Youll Make An Impact
- Patient Coordination
- 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.
- Coordinate and attend pre-study site visits site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives.
- Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
- 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.
- Discuss study medication procedures eligibility criteria and impact on office flow with Investigator and site staff.
- 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.
- Assist in the creation and review of source documents.
- Patient Recruitment
- 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
- Review and assess protocol (including amendments) for clarity logistical feasibility
- Ensure that all training and study requirements are met prior to trial conduct
- Communicate clearly verbally and in writing
- Attend Investigator meetings as required
- Ensure adequate supplies have arrived on site for protocol initiation (lab kits study medication specialized equipment IVRS/EDC access and passwords)
The Expertise Required
- Bilingual in Spanish required
- Ability to understand and follow institutional SOPs.
- 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.
- Bachelors 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
- Licenses:
- California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health
- Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners
- Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health
- Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health
How We Work Together
- Location: This is an on-site position with regional commute requirements located in Dalton Georgia
- Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements staff needs and company initiatives.
- Type of travel required: Regional (within 100 miles)
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
- Walking - 20%
- Standing - 20%
- Sitting - 20%
- Lifting - 20%
- Up to 25lbs
- Over 25lbs Overhead
- Driving - 20%
- Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements staff needs and company initiatives.
The expected salary range for this role is $60000 - $90000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical dental and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we 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 are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to and will not be discriminated against on the basis of 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 is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access please reach out to:
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication arrest or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona Georgia Indiana and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 2938 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW AN EMPLOYER MAY NOT REQUIRE OR DEMAND AS A CONDITION OF EMPLOYMENT PROSPECTIVE EMPLOYMENT OR CONTINUED EMPLOYMENT THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Required Experience:
IC
Key Skills
CSS,Cloud Computing,Health Education,Actuary,Building Electrician
Employment Type : Full Time
Experience: years
Vacancy: 1
Monthly Salary Salary: 60000 - 90000
[job_alerts.create_a_job]
Clinical Research Coordinator II • Chattanooga, Tennessee, USA
Patient Coordinator
Primary Care Clinic Manager II
RN Clinical Manager Home Health
Primary Care Clinic Manager II
OR RN Clinical Coordinator: Elevate Patient Care
Dialysis Clinical Manager Registered Nurse - RN
Patient Coordinator
Remote Oncology Data Specialist-Certified Cancer Registrar
RN Clinical Decision Unit
Endocrinology Opportunity in the Chattanooga, TN area making $300 + Bonus
Laboratory Director
Physician / Cardiology - Interventional / Puerto Rico / Permanent / Field Medical Director, Interventional Cardiology (Remote)
Physical Therapist - Acute Care - Rust Medical Center
Clinical Director 15K Sign On Bonus
Remote CRA II: Site Partnerships & Trial Monitoring
Inpatient Hospital Reimbursement & Coding Spec II - Remote
Travel Telemetry RN
