Clinical Trial Research Coordinator I

Job#: 3020986

Job Description:

Apex Systems is seeking a Clinical Trials Research Coordinator for a major Healthcare company.

** This role is fully onsite in Oakland, CA **

You must be authorized to work in the United States without sponsorship.

Core Duties and Responsibilities:

• Study Management & Compliance: Adhere to, and ensure staff follow, study protocols, FDA regulations, and IRB requirements.
• Participant Management: Recruit, screen, and enroll participants; obtain informed consent; and act as the primary contact to monitor safety and adherence.
• Data Collection & Documentation: Collect, code, and enter patient data into electronic case report forms (eCRFs); maintain accurate and up-to-date study records, including Regulatory Binders and Informed Consent Forms (ICFs).
• Clinical Procedures: Coordinate participant visits, procedures, and tests, which may include collecting and processing biological samples (blood, urine, tissue) and shipping them to labs.
• Safety Reporting: Document and report adverse events (AEs), serious adverse events (SAEs), and protocol deviations to the IRB, sponsor, and PI.
• Liaison & Communication: Act as a liaison between the study team, sponsors, CROs, and IRB.
• Operational & Administrative: Manage study supplies, assist with study initiation/closeout visits, and sometimes aid with budgetary tracking.

Basic Qualifications:

• High School Diploma or General Education Development (GED) required.

• Associates degree or higher preferred

• 2 years of work experience in an ambulatory and/or acute health care setting required (LVN maybe substituted) a plus.

Additional Requirements:

• Willingness to obtain IATA/DOT certification prior to start date.

• Current BLS certification required prior to start date.

• Satisfies requirements for career advancement/maintenance as defined by the Clinical Trial Career Ladder Program.

• Must be proficient in electronic health systems and databases used in research environment and word-processing or willingness to learn within 3 months of hire.

• Knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures.

• Must be able to work in a Labor Partnership environment.

• Demonstrate written, verbal, and interpersonal communication skills.

• Demonstrate proficiency in medical terminology.

• Demonstrate attention to detail and accuracy.

• Demonstrate good prioritization and organizational skills.

• Demonstrated skill in administrative tasks (, filing, photocopying, faxing, etc.).

• Ability to manage multiple tasks.

• Ability to be flexible and dependable.

• Ability to work effectively on cross-functional teams.

• Present professional manner and appearance.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click here for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.