Clinical Research Coordinator (Fixed Term Contract)
About The Position
The Clinical Research Coordinator supports the successful implementation and execution of research and grant-related activities by providing operational, administrative, and project coordination support to the Principal Investigator (PI) and Project Team. This role ensures timely completion of project objectives, facilitates collaboration across teams, and contributes to maintaining high standards of accuracy, organization, and client service throughout all phases of the project. Since our organization is going to change to meet the needs of our stakeholders and to fulfil our business plan, you can expect, anticipate, and assume that your job description will change to meet these challenges.
Requirements
- Excellent written and verbal communication skills in both English and Spanish.
- Outstanding customer service and interpersonal skills when interacting with clients and participants.
- Ability to work collaboratively with team members in a dynamic and fast-paced work environment.
- Manages time and priorities effectively.
- Apply new skills and concepts quickly and display a willingness to learn and improve.
- Superior working knowledge of office applications and online collaboration tools, such as Microsoft 365 Suite, Google products, SharePoint, One Drive, Dropbox, Adobe PDF, Docusign, Zoom, etc.
- Ability to learn new processes and use company-specific software.
- A strong work ethic, ability to maintain and model high personal, ethical, and professional standards, as well as an outgoing and positive personality.
- BA/BS degree in health-related field, or a minimum of three years’ experience in clinical trials research setting as a data manager/CRA/CRC/other similar role.
- Proven work experience as a Clinical Research Coordinator or similar role.
Nice To Haves
- Advanced degree with relevant experienced desired.
- Grant management a plus.
Responsibilities
- Coordinate study start-up activities, including regulatory submissions (IRB/IEC), protocol implementation, and site initiation.
- Develop and maintain study documents such as source documents, case report forms (CRFs), study binders, and standard operating procedures (SOPs).
- Ensure compliance with NIH, FDA, ICH-GCP, and institutional guidelines.
- Identify, screen, and recruit eligible participants according to protocol inclusion/exclusion criteria.
- Conduct informed consent discussions and ensure proper documentation of consent.
- Maintain recruitment logs and track enrollment progress against study targets.
- Schedule and coordinate study visits, procedures, and assessments per protocol.
- Collect, process, and ship biological specimens as required.
- Accurately collect, enter, and maintain study data.
- Ensure data integrity, completeness, and timeliness.
- Maintain essential regulatory documents (e.g., investigator site file, consent forms, training logs).
- Prepare for and support monitoring visits, audits, and inspections.
- Ensure ongoing compliance with NIH policies and reporting requirements.
- Serve as the primary liaison between investigators, sponsors, clinical staff, and participants.
- Coordinate with multidisciplinary teams (e.g., physicians, nurses, lab personnel).
- Participate in investigator meetings, site visits, and study-related calls.
- Track study-related expenses and assist with budget management.
- Prepare progress reports, enrollment updates, and final study reports for NIH and stakeholders.
- Assist with study closeout procedures, including data lock, archiving, and regulatory submissions.
- Maintain current certifications (e.g., GCP, human subjects’ protection).
- Train site staff on study protocol, procedures, and compliance requirements as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
