Job Title: Clinical Research Coordinator

Job Description

The Clinical Research Coordinator (CRC) will perform diverse administrative duties requiring analysis, sound judgement, and a high level of knowledge of study-specific protocols. The CRC will manage multiple clinical trials, adhering to Research SOPs, Good Clinical Practices, and Study Protocols. The role requires direct patient interaction, ensuring informed consent and protocol compliance, and maintaining detailed and accurate records.

ResponsibilitiesAdministratively and clinically manage an average of six to eight clinical trialsAdhere to Research SOPs, Good Clinical Practices, and Study ProtocolsDiscuss Study Protocols with patients and verify informed consent informationProvide patients with written communication of their participation, including copies of signed consent formsMeet with patients for each visit and maintain accessibility to discuss study-related questions or concernsComplete screening visits according to protocol and take detailed and accurate medical historiesGather comprehensive patient information and medical histories prior to screening visits to identify potential issues or exclusionsDispense study medication professionally and accountably following protocol requirementsCollect, process, and ship blood/urine specimens if a Research Assistant is unavailablePerform ECGs and obtain vital signs if a Research Assistant is unavailableSchedule all patient research visits and procedures in line with protocol requirementsComplete and maintain case report forms per FDA guidelines, ensuring accuracy and completeness against patient medical recordsAdminister questionnaires and diaries per protocolDocument and report both non-serious and serious adverse eventsScreen laboratory results upon receipt and follow procedures for abnormal resultsEnsure all laboratory results are reviewed by the Principal Investigator (PI) for clinical significanceKeep delegation logs and training logs current; train staff on new protocol amendmentsReview and comprehend study protocols, proceedings, timelines, inclusion and exclusion criteria, and confidentiality/privacy protectionsAttend investigator meetings as required and approved by the PI and Lead Study CoordinatorCreate study-specific source documentationEssential SkillsActive GCP certificationAbility to read and understand protocols and schedules of eventsMinimum of 5 years of Clinical Research experienceThorough understanding of FDA, ICH, and GCP guidelinesExperience with Phase I-IV clinical trialsProficiency with Microsoft Office SuiteExcellent interpersonal, verbal, and written communication skillsComfort with medical terminology and EKGsBCLS training requiredAdditional Skills & QualificationsIATA certification (preferred)Bilingual abilities, especially Spanish (preferred)Experience at a busy institution with a broad range of research responsibilitiesRN/LVN, Bachelor’s Degree, or equivalent experienceFamiliarity with the full lifecycle of clinical research, from specimen processing to regulatory work
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 & Inclusion

At 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 people

The 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.