Clinical Trial Administrator

Job Duties

Clinical Trial Administrator

Location:

Minneapolis, MN, US

Job Family:

Consumer

Country/Region:

United States

The Clinical Trial Administrator (CTA) fulfils a specialized research role within the Clinical Research department. The CTA supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of a study. This role is responsible for preparing and maintaining Clinical Trial documentation and supervising administrative activities. In performing these duties, the CTA works closely with Clinical Research Associates to support and provide guidance on the administration of all related aspects of a clinical study.

The Clinical Trial Administrator is based in a Kerecis office and reports to the Director of Clinical Affairs. This is a full-time role.

Major Areas of Accountability

Assist in the preparation and maintenance of clinical trial documentation

Submit clinical trials to institutional review boards/ethics committees

Cooperate with Clinical Trials Monitors

Participate in Clinical Trials team meetings

Conduct correspondence and make telephone contact with study sites

Reporting ongoing progress to project manager(s)

Maintain and report identified metrics

Prepare other study materials, including but not limited to enrollment logs, drug/device accountability logs

Prepare applicable submission forms and submit updated documents

Establish and organize study files, including but not limited to study-specific source documentation, regulatory binders and other materials

Assist principal investigator/site in communication

Weekly phone calls to each study center to aid shipment of product and other study materials

Document status of each center's recruitment, number of screened patients, enrolled patients, and their current week status, dropouts, and patients that have completed the study; all study documents should be uploaded and organized appropriately in SharePoint

Prepare monthly status updates on study progress for meetings and the Clinical Newsletter

Prepare agendas and take notes for all Clinical Development team meetings (Project Check-in, Trial Council, Monthly Presentations, etc.)

Serve as Administrative Secretary of Trial Council

Submit and process all vendor/site/contractor invoices in a timely manner upon receipt and follow up with Finance and Accounting until approved. Ensure Net 30 payment terms are adhered to

Submit required POs for study center recruitment and materials for the trial

Compile study binders for sites and ship them to sites as needed

Track documentation required for each center and file them appropriately

Label study material appropriately with designated stickers and Serial Numbers, as needed, to prepare for shipment to sites

Request Kerecis and control material for study and facilitate shipment of study materials to sites

Anticipated travel <5%

Kerecis employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Other job duties as assigned

Basic Qualifications

One year of experience as a clinical research coordinator

Experience managing device or pharmacology trials or evidence of experience/education in clinical studies

Very good knowledge of the English language (enabling free verbal and written communication and understanding of content related to the field of clinical research)

Conscientiousness, precision and consistency in carrying out assigned tasks

High interpersonal skills

Ability to work with a large team

High level of motivation and commitment

High organizational skills (setting priorities and managing multiple tasks)

Experience with processing payments / invoices through accounting and finance departments

Openness to new challenges and willingness to continuously improve skills

Knowledge of ICH GCP principles an asset

Good knowledge of Microsoft Office suite

Effective time management

Communicativeness, ease in establishing contacts

Preferred Qualifications

Bachelor's degree in science-related field from an accredited college or university preferred

Base Salary Range: $65,000 - $85,000

This job description is intended to set forth the core functions required for this position and describe the general nature of the work to be performed. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job. Job duties, responsibilities and activities may change or be supplemented at any time as necessary. Kerecis is an Equal Opportunity Employer.

61975

#LI-KR

Nearest Major Market: Minneapolis

Apply now

EOE M/W/Vets/Disabled

Minimum Education Required

High School Diploma or Equivalent

Minimum Experience Required

1 - 20 years

Shift

First (Day)

Number of Openings

1

Public Transportation Accessible

Yes

Veterans Encouraged to Apply

No

Physical Required

Yes

Drug Test Required

Yes

Compensation

$11.41 / Hourly

Postal Code

55411

Job Type

Full Time

Place of Work

On-site

Requisition ID

61975

Job Benefits

Not specified