Clinical Trials Coordinator II at Actalent, Durham, NC
Clinical Trials Coordinator II at Actalent, Durham, NC
Description:
The CTC II develops, coordinates and implements the management of the clinical endpoint adjudication process for clinical trials research conducted by Principal Investigator(s). The CTC II also performs a variety of duties involved in the organization, oversight, documentation and compilation of clinical research data. The CTC II is also responsible for the skills and responsibilities at the CTC I level.
Responsibilities
Demonstrate in-depth knowledge of study protocols, relevant SOPs and clinical endpoints through accurate, timely and efficient management of CEC events with proven ability to effectively support study start-up and routine study activities. Effectively conveys CEC Study knowledge as requested for training of team members and new employees
•Prepares presentations of CEC related study activates, including endpoint definitions and review process, for project teams and investigator meetings. Coordinates the work of CEC team members working on CEC aspects of the trial to ensure accurate and timely classifications of clinical events based on source documents and other clinical data, according to study specifications and SOPs. Effectively and efficiently resolves queries and questions from study team relative to CEC data. Manages and review process to ensure adherence to study specifications, including resolution of reviewer inconsistencies.
•Reviews CRF/eCRF to assure congruence with CEC Study protocol and endpoints specifications. Identifies and works to resolve issues that place data integrity at risk. Ensures team members receive and documents study specific training. Coordinates CEC aspects of interim analyses, and trial closeout, providing input to report development, reviewing for accuracy and appropriateness to purpose.
•Applies proactive approach to identify, escalating as needed, potential study risks and quality concerns. Responsible for study adherence with quality, compliance and SOP standards. Provides input to management of project budgets and forecasting as well as review of scope of work and tasks.
•Demonstrates the ability to review data sets to identify unreported potential endpoints and serious adverse events.
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Skills:
Clinical research, adjudication, CRF, RN, CRF Review, CRA, Critical Care
Top Skills Details:
Clinical research, adjudication, CRF, RN
Additional Skills & Qualifications:
1-2 years safety experience, RN, CRC, CRA or CTA exp
Completion of RN/PA/Pharmacist training and 2 years healthcare experience; or allied health degree and 5 years healthcare experience; or advanced degree in public health/related field and 1 year clinical trials research experience; or BA/BS and 3 years clinical trials research experience.
Experience Level:
Intermediate Level
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
Actalent is an equal opportunity employer.
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About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
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