Clinical Research Coordinator - Actalent : Job Details

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.

Responsibilities

+ Administratively and clinically manage an average of six to eight clinical trials

+ Adhere to Research SOPs, Good Clinical Practices, and Study Protocols

+ Discuss Study Protocols with patients and verify informed consent information

+ Provide patients with written communication of their participation, including copies of signed consent forms

+ Meet with patients for each visit and maintain accessibility to discuss study-related questions or concerns

+ Complete screening visits according to protocol and take detailed and accurate medical histories

+ Gather comprehensive patient information and medical histories prior to screening visits to identify potential issues or exclusions

+ Dispense study medication professionally and accountably following protocol requirements

+ Collect, process, and ship blood/urine specimens if a Research Assistant is unavailable

+ Perform ECGs and obtain vital signs if a Research Assistant is unavailable

+ Schedule all patient research visits and procedures in line with protocol requirements

+ Complete and maintain case report forms per FDA guidelines, ensuring accuracy and completeness against patient medical records

+ Administer questionnaires and diaries per protocol

+ Document and report both non-serious and serious adverse events

+ Screen laboratory results upon receipt and follow procedures for abnormal results

+ Ensure all laboratory results are reviewed by the Principal Investigator (PI) for clinical significance

+ Keep delegation logs and training logs current; train staff on new protocol amendments

+ Review and comprehend study protocols, proceedings, timelines, inclusion and exclusion criteria, and confidentiality/privacy protections

+ Attend investigator meetings as required and approved by the PI and Lead Study Coordinator

+ Create study-specific source documentation

Essential Skills

+ Active GCP certification

+ Ability to read and understand protocols and schedules of events

+ Minimum of 5 years of Clinical Research experience

+ Thorough understanding of FDA, ICH, and GCP guidelines

+ Experience with Phase I-IV clinical trials

+ Proficiency with Microsoft Office Suite

+ Excellent interpersonal, verbal, and written communication skills

+ Comfort with medical terminology and EKGs

+ BCLS training required

Additional Skills & Qualifications

+ IATA certification (preferred)

+ Bilingual abilities, especially Spanish (preferred)

+ Experience at a busy institution with a broad range of research responsibilities

+ RN/LVN, Bachelor's Degree, or equivalent experience

+ Familiarity 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 [email protected] ( [email protected]) for other accommodation options.