Job Summary:

The Clinical Research Associate (CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities of a CRA include ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. CRAs may be required to travel up to 65%.

Responsibilities:

- Participate in the design and execution of global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management.

- Manage study preparation, activation, enrollment, submission, maintenance and closure activities.

- Participate in administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets.

- Interface with representatives from key functional groups to drive product development within core teams, and clinical wide or cross-departmental initiatives.

- Ensures appropriate oversight of clinical study by internal and external resources including, but not limited to monitoring staff, CROs and core laboratories.

- Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.

- Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers.

- Supervise training of investigators, site staff and field clinical staff.

- Evaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents.

- Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions.

- Regularly communicates study status to senior management and represents organization to key customers.

Skills:

- Detail-oriented

- Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills

- Flexibility with changing priorities

- Ability to efficiently perform and prioritize multiple tasks

- Familiarity with the medical and pharmaceutical industries, and related terminology and practices

- Extensive knowledge of FDA regulations and their practical implementation

- Computer proficiency in Microsoft Word, Excel, and PowerPoint.

If you are a dedicated professional looking for an opportunity to contribute to groundbreaking research, we encourage you to apply. Join our team as a Clinical Research Associate and make a difference in the field of healthcare.

Job Type: Full-time

Pay: $60,000.00-$80,000.00 per year

Benefits:

Dental care
Paid time off
Vision care

TruMinds Technology Inc

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Clinical Research Associate