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Description:

• Participate in the coordination of multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet objectives of assigned research protocol(s).

• Assesses patients for protocol eligibility and communicates findings to Principal Investigator.

• Coordinates the implementation of protocol procedures.

• Assesses and monitors patient responses and adverse reactions; reports same to accountable sources. Provides appropriate patient and family education.

• Completes a variety of reports, documents and correspondence for regulatory agencies, participating clinical trial sites and for internal purposes.

• Collaborates with Principal Investigator and study team to ensure adherence to FDA and protocol guidelines; identify potential problems and/or inconsistencies and act as appropriate.

• Assist in the preparation and submission of amendments to clinical trials protocols to the IRB.

• Provides educational in-services as needed. Promotes interdepartmental cooperation and coordination for each protocol.

• Flexibility to travel to all BPEI sites as needed

• Establishes patient/participant screening procedures with Principal Investigator and obtains relevant medical information from patient clinic charts/medical records.

• Ability to handle multiple clinical trials with several principal investigators

• Serve as back up coordinator to other clinical trials

• Completes corrections/queries required at audits/monitor visits and takes action to correct deviations as needed.

• Establishes/maintains contact with patient/participants, health care providers, community agencies and study sponsors.

• Updates appropriate agencies (such as sponsors, IRB, etc) regarding current status of research project. Provides in-service education to staff and patients/participants about research protocols

• Prepares and submits annual reviews to the Institutional Review Board (IRB). Maintains consent forms and sponsor correspondences. Notifies IRB of protocol amendments, safety reports and serious adverse events, etc. in compliance with applicable regulations

• Implements research protocol and monitors participant adherence to protocol

• Maintaining and starting complex clinical trials

Skills:

Chart review, Pre-screening patients, Clinical trial, Edc, Patient recruitment

Top Skills Details:

Chart review,Pre-screening patients,Clinical trial

Experience Level:

Intermediate Level

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.