CAMRIS · 4 hours ago
Clinical Research Coordinator I
San Diego, CA
Full-time
Onsite
Entry Level
$70K/yr - $73K/yr
5+ years expCAMRIS International, LLC is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges. They are seeking a Clinical Research Coordinator I to support the Naval Health Research Center by coordinating and managing clinical research studies, focusing on infectious diseases among military populations.
BiotechnologyInformation Technology
No H1B
Security Clearance RequiredU.S. Citizen Only
Responsibilities
Patient Recruitment and Consent: Identifies, recruits, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines
Help lead recruitment efforts, developing and refining strategies to meet enrollment targets
Make independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria
Manage and coordinate complex clinical trials: Handle complex logistics of trials, solve problems related to compliance or participant concerns, and make adjustments to protocols based on emerging situations during the study
Study Protocol Design and Oversight: Interprets study protocols, assessing feasibility, and modifies procedures to align with the objectives of clinical trials
Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures
Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS)
Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings
Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines
Compliance and Regulatory Decisions: Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards, and addressing issues without minimal supervision by the Clinical Program Manager
Regulatory Management: Assists with Institutional Review Board (IRB) submissions and protocol amendments
Collaborate with principal investigators and sponsors and provide insights based on field experience
Recommend changes to improve study feasibility and evaluate the implications of protocol adjustments on ongoing activities
Ensures compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system
Compliance and Monitoring: Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle
Ensure that the research team follows procedures. Troubleshoot and resolve any deviations or challenges that may arise
Develop and implement quality control procedures, identify areas for improvement, and resolve any issues that could impact the validity or integrity of the study outcomes
Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies
Regulatory Responsibilities: Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements
Ensures all study-related documents are appropriately filed and accessible for audits
Manages study registrations and updates in the Clinical Trial Management System and eIRB system
Other Responsibilities: May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel
Remote and On-Site Study Leadership: Conduct research activities in varied environments, such as on naval ships or other remote sites, which may involve travel
Coordinate logistics, including equipment and resource allocation, and serve as a research team representative on-site
Make real-time decisions regarding study operations and troubleshoot unexpected scenarios to ensure study fidelity and safety
Performs other duties as assigned
Qualification
Required
A BA/BS in biological sciences, public health, or equivalent OR five (5) plus years of clinical research experience
Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes
Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems
Strong organizational, communication, and problem-solving skills
Ability to work both independently and collaboratively in a research setting
US Citizenship and the ability to obtain and maintain a T3/Secret Clearance
Preferred
Certification in clinical research (such as CCRC or CCRP)
Experience with infectious disease studies or military health research
Benefits
Medical, dental, and vision insurance for individuals and families
FSAs
HSA
Life and AD&D insurance
Short- and long-term disability
Legal services
Voluntary hospital indemnity
Critical illness and accident insurances
EAP
Pet insurance
401(k) with employer match and Roth option
Tuition and professional reimbursement
Public transportation support in the DMV area
A referral bonus program
Vacation with tenure-based increases
PTO
11 paid holidays
Paid bonding leave
Paid supplemental short-term disability
Company
CAMRIS
CAMRIS is a military medicine, clinical and life sciences, and research and development firm with experience working in more than 110 countries.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2020-10-05Acquired
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