What are the responsibilities and job description for the Clinical Research Coordinator position at Actalent?
Description:
Candidate will a lot of data entry, protocol reviews, meetings with study team members, preparing for study visits (not to see patients but ensuring lab kits are all set, questionnaires are ready, any scans that might be needed etc.), Clinical Research Coordinator II performs a full range of clinical research duties at a skilled level and has a working knowledge of the clinical research process and the regulations that govern it. The expectation is to perform progressively more complex and comprehensive clinical research duties with an increasing level of independence, working closely with the Principal Investigator (PI). The Clinical Research Coordinator II works under the supervision of and at the direction of the PI or their designee. They cannot perform any tasks that state or local law require a license to perform. Key Responsibilities: - Understands and supports all of aspects of the study operations (including subject management/regulatory) with oversight from the investigator or their designee. - Primarily supports subject management, such as data entry in the Clinical Trial Management System(CTMS), scanning informed consents into EMR, and supporting data entry needs of the study. - May carry out study visit tasks such as administering Quality of Life (QoL) questionnaires under supervision of investigator. - Maintains study and regulatory documentation. - Utilizes the Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations - Scores tests, enter data, and completes Case Report Forms (CRFs, eCRFs) accurately and according to protocol. - Develops or assists with the development of data collection documents and instruments and procedures for data quality assurance. - Monitors for and identifies potential issues related to data capture, collection or management and suggests solutions. Investigates incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. - Organizes and manages clinical trials and research studies. - Serves as a liaison between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems. - Identifies and recognizes the respective roles of team members. - Understands and upholds the importance of an interdisciplinary team and the value each member can bring to clinical studies. - Performs other duties as required or assigned.
Skills:
Clinical research, Clinical trial, Gcp, Regulatory, Irb
Top Skills Details:
Clinical research,Clinical trial,Gcp,Regulatory,Irb
Additional Skills & Qualifications:
Minimum Qualifications: - Bachelors or equivalent years of experience - 2 years of relevant research experience - SOCRA/ACRP Certification or eligible for certification preferred
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.
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.
Salary : $28 - $30
