Clinical Research Coordinator - Lufkin, TX

SiteBridge Research, Inc.; Lufkin (TX); Vor Ort; USD 65.000 - 80.000; Vollzeit

Zusammenfassung

SiteBridge Research Inc. in Lufkin, TX seeks a Clinical Research Coordinator to support the Principal Investigator and Clinical Research Nurse across multiple studies.

The role involves daily trial operations, collaboration with the site team, sponsors, and monitors to ensure timely completion and regulatory compliance. The position is onsite in Lufkin, with responsibilities including participant communication, screening, consent, data management, and regulatory documentation.

Qualifikationen

• Bachelor’s degree in a life science discipline is required.
• 3+ years of experience in clinical site or trials is required.
• Cardiology experience is a plus.
• Knowledge of FDA and ICH GCP regulations is required.
• Detail-oriented and meticulous in all aspects of work.

Aufgaben

• Communicate with study participants regarding objectives.
• Administer questionnaires and monitor protocol adherence.
• Oversee activities to ensure regulatory compliance and ethics.
• Maintain study records including CRFs and regulatory forms.
• Manage participant screening, consent, and intake assessments.
• Track enrollment across all site trials and provide progress updates.
• Prepare protocol worksheets, AE reports, IRB documents and progress reports.
• Ensure compliance with local, state, and federal regulations per ICH/GCP.
• Create and maintain essential study documentation and records.
• Communicate study progress to the PI and Site Operations leads.
• Stay updated on protocols and regulatory requirements to ensure study success.
• Willingness to travel up to 25% as needed.

Kenntnisse

Interpersonal skills

Analytical mindset

Communication

Attention to detail

Problem solving

Ausbildung

Bachelor’s degree in life science

Tools

MS Office

Jobbeschreibung

SiteBridge Research Inc

Founded in 2021, SiteBridge Research is an integrated research organization, focused on building a national network of small and community medical practices to deliver world-class industry-sponsored clinical research studies on time and on budget, accelerating time to completing clinical trials, accelerating time to market and product adoption in communities that are often underrepresented and difficult to reach. The SiteBridge Network extends reach further into these communities to empower patients with some of the highest unmet needs to take part in clinical studies to improve inclusivity in clinical research and to improve overall health outcomes.

Job Description: Clinical Research Coordinator (Lufkin, TX)

The Clinical Research Coordinator supports the clinical Principal Investigator (PI) and Clinical Research Nurse across multiple ongoing research studies. In this role, the study coordinator assists and facilitates daily clinical trial operations, playing a key part in successful study execution. The role involves close collaboration with the site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, optimize site efficiency, and support timely study completion.

The position is located in Lufkin, Texas and is 100% onsite.

Responsibilities

• Communicate with study participants regarding study objectives


• Conduct questionnaire administration and monitor participant compliance with study protocols


• Oversee study activities to ensure adherence to protocols, ethical conduct, and applicable regulatory standards


• Maintain research records of study activity, including case report forms, drug dispensation records or other regulatory forms as per FDA guidelines


• Manage clinical study and staff records related to clinical study activity


• Manage participant screening and recruitment by scheduling study visits, obtaining informed consent, and conducting protocol-required intake assessments


• Track and manage participant enrollment across all site clinical studies


• Prepare trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports


• Maintain compliance of clinical studies with applicable local, state, and federal regulations, in alignment with ICH/GCP guidelines


• Create, organize, and maintain essential study documentation and records to ensure accuracy and compliance


• Communicate ongoing study progress to the Clinical PI and Site Operations leads, including updates on recruitment, compliance, and overall study performance


• Stay updated on the latest research protocols and regulatory requirements to ensure compliance and contribute to the successful completion of the study


• Willingness to travel up to 25% as needed.

Qualifications

• Requires Bachelor’s degree in a relevant life science discipline


• 3+ years of previous experience working in clinical site/trials


• Prior experience in the cardiology therapeutic area is a plus


• Knowledge of FDA & ICH GCP regulations and guidelines is required


• Detail-oriented and meticulous in all aspects of work


• Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative


• Medical terminology and scientific knowledge are a plus


• Knowledge of standard clinical procedures and protocol


• Analytical mindset: needs analytical skills to collect and interpret data, taking note of patterns or outcomes that those in charge of the trial need to be aware of


• Excellent interpersonal skills, with the ability to effectively communicate and resolve issues while working with the PI, participants, and key stakeholders.


• Exceptional written and verbal communication skills, with the ability to clearly convey study requirements to participants and effectively liaise with site and management staff


• Skilled with standard computer programs including the MS Office suite.

Additional Information

SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills, and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements, and individual qualifications and performance.