Job Description
The Clinical Research Coordinator II conducts and manages multiple clinical trials from start-up through study close-out in accordance with the study protocol, GCP, and SOPs. This role involves implementing and coordinating clinical trials, managing vendor relationships, recruiting subjects, and ensuring all regulatory requirements are met.
ResponsibilitiesConduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and SOPs.Implement and coordinate assigned clinical trials including start-up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, and ensuring data is entered in a timely manner.Resolve all queries, manage and report adverse events, serious adverse events, and deviations, implement new protocol amendments, and provide all close-out activities.Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries.Maintain confidentiality of patient protected health information, sponsor confidential information, and proprietary information.Verify and escalate patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and SOPs.Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner.Ensure staff are delegated and trained appropriately and documented.Create, collect, and submit regulatory documents to sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.Evaluate potential subjects for participation in clinical trials including phone and in-person pre-screens.Create and execute recruitment strategies defined by the team.Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.Understand the product development life cycle and significance of protocol design including critical data points.Understand the disease process or condition under study.Collaborate to develop a Quality Control strategy for reviewing work on an ongoing basis and in preparation for monitor visits.Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope.Essential SkillsExperience with clinical trials and research.Proficiency in pre-screening patients and obtaining consent.Bilingual capabilities.Phlebotomy skills.Clinical research experience.Experience with electronic data capture (EDC) systems.Additional Skills & QualificationsBachelor’s degree and 2 years relevant experience in the life science industry ORAssociate’s degree with 4 years relevant experience in the life science industry ORHigh School Graduate and/or technical degree with a minimum of 6 years relevant experience in the life science industry AND1 year Clinical Research Coordinator experience.Work Environment
This position is onsite and offers private examination/consultation rooms, comfortable patient reception areas, facilities for extended-stay pharmacokinetic studies, parking, a nursing station, secure monitoring rooms or workstations with phone & high-speed internet access, multiple individual & secure workstations for research staff, a regulatory document processing area, and electronic data capture capabilities. The facility also includes secure record storage, a CLIA certified research laboratory or clinical laboratory with a CLIA waiver, ambient and refrigerated centrifuge, secured & temperature-controlled investigational product storage with pharmaceutical refrigerator & freezer, freezers equipped for laboratory specimens at -20 & -70 degrees Celsius, a backup generator/power source in the event of site power loss, and standard medical equipment, including ECG machines, digital and analog scales.
Pay and Benefits
The pay range for this position is $64400.00 - $72800.00
Health and Wellness Benefits
Medical, dental, vision, HSA, and FSA plans
Employer contributions from 55-80% based on coverage level
Company contributions to HSAs
401k Eligibility and Company Match
100% match of the first 3% of contributions; 50% on the next 2% contributed
Immediate eligibility and automatic enrollment at 5% contribution
Paid Time Off and Company Holidays
PTO starting at three weeks per year and growing with company tenure
10 paid holidays each calendar year
Life Insurance and Employee Assistance Program
100% paid life Insurance policy (double annual salary)
100% paid short- and long-term disability benefits
Optional insurance coverage for the employee and dependents
Complimentary emergency assistance plan
Site Incentive Bonus Plan
Site bonuses are paid twice annually
Ties site team success to Velocity's success
Recognition and reward for individual contributions
Workplace Type
This is a fully onsite position in Gardena,CA.
Application Deadline
This position will be accepting applications until Jan 29, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.