Remote Women's Fertility Clinical Research Associate III

RemoteRemoteFull TimePosted 25 days agoVisa sponsorship availableHidden Gem · Himalayas

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Required skills

site management
field monitoring
clinical trials
communication skills
planning skills
project plans
leadership skills
time management skills
computer skills
Microsoft Word

Nice to have

womens fertility
VD Study Experience
Medidata RAVE

Role summary

Seeking a Remote Clinical Research Associate III with a BS/BA and a minimum of 2 years of experience in site management and field monitoring. The role requires knowledge of clinical trial regulations, strong planning, communication, and interpersonal skills, as well as proficiency in Microsoft Office. The associate will perform site monitoring visits, ensure data accuracy, manage site communication, resolve queries, and maintain site files. Experience in women's fertility and Medidata RAVE is preferred.

Remote Clinical Research Associate III needs 2 years of site management and field monitoring experience

Remote Clinical Research Associate III requires:

Work Schedule: M-F 7:00 am -3:30 pm or 8:00 am to 4:30 pm

EST

Qualifications:

BS/BA

Minimum of 2 years of site management and field monitoring experience

Knowledge of applicable standards and regulations for clinical trials

Proven oral and written communication skills

Proven planning skills; ability to create and track detailed project plans

Proven interpersonal, leadership, organizational and effective time management skills

Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates

Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion

Preferred:

Experience in womens fertility
VD Study Experience
Medidata RAVE system

Remote Clinical Research Associate III duties:

Performs Site initiation, interim & close out monitoring visits

Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete

Manages site communication and escalates to leadership in a timely fashion when needed

Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines

Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).

Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

Documents activities via confirmation letters, follow-up letters, trip reports

Site support throughout the study lifecycle from site identification through close-out Attends and participates in internal meetings

Originally posted on Himalayas

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