Clinical Trial Assistant job Alpharetta Georgia
Clinical Trial Assistant job Alpharetta Georgia
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Clinical Trial Assistant Job

Employer Name: Advanced Recruiting Partners SpiderID: 7992514
Location: Alpharetta, Georgia Date Posted: 9/24/2018
Wage: $25/hr. - $35/hr. Category: Biotech
Job Code:
Number Of Openings: 2

Job Description:
JOB SUMMARY / RESPONSIBILITIES for the Clinical Trial Assistant (CTA):
• The Clinical Trial Assistant (CTA) will assist the Study Manager in training CRO CRAs and creating the CRA training material Attend co-monitoring visits as required per the Sponsor Oversight Plan and/or Monitoring Plan, or as needed Review Monitoring Visit Reports from the CRO Monitor studies (PSV, SIV, IMV, COV) as needed. Escalate monitoring trends or findings to the Study Manager Track metrics related to Sponsor Oversight and the Monitoring Plan.
• Assist in start-up activities of clinical research studies including Investigator Meetings, enrollment planning, and Investigator selection Collaborates closely with study management, CRO study managers, and CRO monitoring staff, reviews site/patient activity tracking, prepares study updates and proactively identifies and solves study-related issues.
• Regularly communicates with Investigators to identify and resolve complex clinical study conduct issues and ensures site compliance with Good Clinical Practice, and federal and applicable local regulatory requirements; Guides investigative site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability.
• Reviews and provides input to study plans and guidelines, including study monitoring plans; Assists in development of study documents, such as informed consent forms, study logs, and study manuals. Provide overall tactical support for the study Lead or assist with TMF processes: set-up, training, QC, management Collaborate with CRO counterpart.

Any interested candidates please send your resume to Wesley Garrett at

Job Requirements:
EDUCATION & QUALIFICATIONS for the Clinical Trial Assistant (CTA):
• BS/BA degree or equivalent and 4 years’ experience in clinical development and operations.
• At least 2 years experience performing on-site monitoring conducting SIVs, IMVs, and COVs for IND regulated clinical research studies.
• Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
• Demonstrated effectiveness in resolving site management issues of varying complexity
• Co-monitoring experience required
• Strong communication and interpersonal/team skills.
• Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project preferred.
• Established ability to prioritize and manage multiple tasks simultaneously.
• Demonstrated ability to identify and resolve issues, and effectively manage timelines.
• Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player.

Job Criteria:
Start Date: 10/8/2018
Position Type: Contractor
Years of Experience Required: 4
Education Required: Bachelors
Overnight Travel:
Vacation Time: 2 weeks / year

Job Benefits:
Health/Dental Benefits, Retirement Benefits, Paid Holidays, Vacations, and Sick Leave, Life and/or Disability Insurance, Tuition Reimbursement

Contact Information:
Contact Name: Wesley Garrett Company Type: Staffing Agency
Company: Advanced Recruiting Partners
City: Raleigh
State: North Carolina
Zip: 27613

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