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Sr. Clinical Research Coordinator

4 months ago

Malden, United States US Tech Solutions Full time

Duration: 9 months contract (Possibilities of extension)


Job Description:

· The Senior Clinical Research Coordinator (CRC) is responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, as well as documenting and reporting on the daily operations of assigned trials. Working in collaboration with the Principal Investigator, the Sr. CRC is responsible for the oversight, facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The Sr. CRC works collaboratively with the entire team, sponsors, and Clinical Quality Associates to ensure productivity, quality, and timely completion of studies.

· The Sr. CRC is expected to support, guide, train, demonstrate and lead clinical trial team members in the implementation of trial related activities. The Sr. CRC applies critical thinking and creative problem-solving skills across a wide variety of clinical studies, and contributes to the development of new processes, procedures, tools, and training to enhance clinical research activities and is accountable for adhering to quality standards.


Responsibilities:

· Manages and oversees the day-to-day operations in the administration of clinical trial activities at the site-level (i.e., direct interactions with study participants). An obesity trial & managing diabetes. The sponsor is looking for two SCRC's onsite & a Registered Dietician, who can be onsite with the participant.

· Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol.

· Opportunity to be a part of clinical trials in a pharmacy. Bringing the trials to the people at their local pharmacy. Can sit anywhere Chicago/ East Coast preferred. Hybrid. Up to 50% travel.

· Working on all trials within the delivery operation team.

· Creates standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations.

· Contributes to the training of clinical trial staff and accountable for compliance with the operational requirements of the clinical trial.

· Function as participants’ primary point of contact, keeping them informed on the study progress, and facilitate involvement of other study team members, as needed (e.g., notify Principal Investigator of safety events)

· Manage participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s)

· Solicit and record information regarding safety events and preparing safety event documentation for review by the Principal Investigator

· Provides accurate and timely data collection, documentation, entry, and reporting in both Sponsor and databases.

· Supports the regulatory staff in the maintenance of regulatory documents in accordance with SOPs and applicable regulations.

· Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.

· Maintain regular contact with the Principal Investigator and team to review study details (e.g., progress, adverse events, enrolment)

· Maintain study supplies and issue appropriate participant stipends.

· Ensures appropriate credentialing and training of the study team.

· Facilitate meetings with the study monitors, auditors, and investigators.

· Ensure timely response to queries and documentation of study-related issues.

· If applicable, disburses investigational product, manages inventory of equipment and study supplies, and provides patient education regarding administration, as necessary.

· Contribute to the development and implementation of tools, processes, and training to enhance the administration and execution of clinical studies (e.g., GCP, ALCOA-C)

· Accountable for site compliance with subject safety reporting, escalate issues.

· Demonstrate professionalism and apply basic leadership practices in all aspects of the role.

· Train and support study team members on a range of communication and teamwork best practices

· Performs other duties related to the clinical trials as delegated by the Principal Investigator


Experience:

· 3-5 years in clinical trial space


Skills:

· Working knowledge of ICH-GCP, US CFR, and HIPAA regulations

· Experience working independently and making appropriate decisions to operationalize and move clinical trials forward. The SCRC is going to be running the protocol for the study. Each patient on the trial will be on it for 19 months, conducting the visits, collecting all the information, entering it into the sponsors data base, basically collecting everything for the protocol. If they have experience in diabetes or obesity that would be a plus. They will be the only SCRC at the site, so they should have experience reading a protocol processing samples & shipping it out & can work independently.

· Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail

· Experience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing priorities.

· Proficient with phlebotomy. Decentralized/hybrid clinical trials experience.

· Collecting all the information, entering it into the sponsors data base, basically collecting everything for the protocol. Looking for a senior person who has experience in clinical trials. If they have experience in diabetes or obesity that would be a plus. They will be the only SCRC at the site, so they should have experience reading a protocol processing samples & shipping it out & can work independently.


Education:

· High School Diploma or associate degree.


About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.


US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


Recruiter Details:

Name: Sagar

Email: sagar.sharma@ustechsolutionsinc.com

Internal Reference Id: 24-10779