Sr. CTA

Job#: 1304940

Job Description:

Senior Clinical Trial Associate 1304940

Location: Remote with some domestic travel
Science: Microbiome
Therapeutic Area: Infectious Diseases, Inflammatory Disease
Job Overview: You will be responsible for assisting in the overall management of clinical trials -including planning execution and closeout.

Responsibilities:

• Assist the Clinical Project Manager in site management activities. This could include review of monitoring reports, tracking of site visits, and assisting with contract review
• Work closely with clinical project managers to assist with preparation of all external and internal documentation for assigned trials to ensure it's completed in accordance with Google Cloud Platform regulatory requirements and consistent with the study protocol. This includes the ability to provide input into the protocol and study plans
• Assist in the creation of and distribution of study materials and communications to KOLs, CROs and other external vendors
• Organize and prepare study files related to study tracking and reporting and submit them to the electronic TMF within established guidelines, maintain up-to-date documentation for all study sites globally
• Preparing training materials and supporting trainings
• Assist the project team with planning, preparation and possible on-site support of investigator's meetings
• Support invoice and budget activities, including contract execution

Qualifications:

• Bachelors Degree in the life sciences or healthcare preferred
• 2 years' of clinical trial experience supporting clinical studies at a CRO, biotech or pharmaceutical company (must have held the title of Sr. CTA previously)
• Working knowledge of ICH Google Cloud Platform regulations and clinical protocols
• Strong interpersonal, organizational and multi-tasking skills
• Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.



Code:ClinOps

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or