Sr Central Services Coordinator

Job Description

Job Description

SUMMARY : The Sr Central Services Coordinator oversees the daily function of multi-site clinical research programs on required protocols. The Sr Central Services Coordinator works virtually with the central services team, on-site clinical staff, and patients to ensure protocols are met.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1)Comply with all company policies, procedures, and conduct.

2)Strictly adhere to confidentiality and compliance standards.

3)Lead the Central Services team in virtual clinical research coordination of study subjects and quality study protocol adherence.

4)Oversee quality standards of the Central Services processes and protocols.

5)Train and oversee Central Service Coordinators and Central Service Coordinator JRs.

6)Communicate the efficiency and productivity results of the team to management and actively source solutions for improvements.

7)Virtually communicate effectively and courteously with study patients via tele-health platform.

8)Demonstrate a caring and pleasant demeanor toward patients and their families.

9)Acknowledge study patients' needs and tend to them appropriately.

10)Collects patient medical history and conditions.

11)Conduct study visits across all sites via tele-health platform.

12)Ensure Informed Consents are obtained by on-site staff.

13)Participant study visit review and completion.

14)Ensure data quality.

15)Collect and evaluate medical records for compliance.

16)Conduct A / E and SAE assessments.

17)Maintain and update regulatory files.

18)Ensure accuracy of data collected.

19)Review study e-source documents to comply with study protocol.

20)Manage all required study documentation, training, and timelines on assigned study protocols.

21)Participate in CRO / Sponsor / Audit interactions.

22)Meet deadlines and goals as assigned.

QUALIFICATION REQUIREMENTS : To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and EXPERIENCE :

1)Associate’s degree in healthcare or related field, preferred.

2)4+ years experience working in Clinical Research, required.

3)4+ years experience in leading clinical teams.

4)2 years experience in healthcare, required.

5)2 years experience in FDA regulations and GCP.

6)Comprehensive knowledge of FDA, GCP and HIPAA as applied to clinical research.

7)Knowledge of current studies being conducted.

8)Comprehensive knowledge of company's SOPs, policies and Confidentiality agreements.

9)Knowledge of safety hazards and procedures that establish a safe work environment.t

10Skilled in computer and data collection software

11)Excellent customer service skills with internal and external stakeholders.

12)A proven ability to multi-task in a rapidly changing environment.

BENEFITS :

• 401 (k) Retirement Plan
• Medical, Dental, and Vision Insurance
• Paid Time Off (PTO)
• Floating Holidays
• And more!

WORK LOCATION : Irving, Texas