Associate Clinical Study Manager

Worldwide Clinical Trials; San Antonio (TX); On-site; USD 75,000 - 100,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate, Clinical Study Manager to oversee site-level monitoring and support Phase I-IV trials across local, regional or global scopes. The role supports the CSM with directing the technical, financial, and operational aspects to ensure the successful completion of the clinical trials.

Responsibilities include coordinating monitoring visits, collaborating with clinic departments, managing approval and signature forms, training documentation, and

Qualifications

• Bachelor’s Degree in Life Sciences or Health, or 4 years clinical research experience.
• Associates Degree with 2 years clinical research experience.
• Min 1 year as a Clinical Research Coordinator preferred.

Responsibilities

• Coordinate study monitoring visits, including access to electronic systems and study documents.
• Collaborate with clinic departments to answer queries in a timely manner.
• Manage and store signed approval forms for Clinical Lab, PK processing, Clinspark Go live, and training/access forms.
• Coordinate signature forms for SIV attendance, logistics meetings, and protocol training-related meetings.
• Ensure staff training is documented in the study files, adhere to SOPs and GCP/regs.
• Facilitate shipment of samples to bioanalytical labs per timeline or client request.

Skills

communication

planning

organization

urgency

adaptability

problem-solving

independence

negotiation

customer service

Education

Bachelor's Degree (Life Sciences or Health)

Associates Degree + 2 years clinical research experience

Job description

What the Associate Clinical Study Manager does at Worldwide

The Associate, Clinical Study Manager will be responsible for the site-level monitoring activities of on one or more allocated Phase I through IV Clinical Trials that may be local, regional, or global in scope. Supports the CSM with directing the technical, financial, and operational aspects to ensure the successful completion of the clinical trials. Works with functional area leads to identify and evaluate essential project prerequisites. The ACSM cooperates with the CSM to ensure all project deliverables meet client’s time/quality/cost expectations.

What you will do

• Coordinate study monitoring visits, to include (but not limited to): ensuring the monitor has access to the relevant electronic systems, reserving monitoring space, assembling study documents for CRA review, and ensuring all follow-up action items are completed in a timely manner.
• Work collaboratively with other clinic departments to ensure all queries are answered in a timely manner.
• Manage and store signed approval forms for Clinical Lab, PK processing, Clinspark Go live, and Clinspark training and access request forms from clients.
• Coordinate and collate signature forms for SIV attendance, logistics meetings, and any other protocol training related meetings, file in the appropriate study folder.
• Ensure staff training is documented in the appropriate study files on the study protocol and other related processes, adhere to professional standards and to SOPs as well as current Good Clinical Practice (GCP) and applicable local regulations.
• Facilitate shipment of samples to bioanalytical labs for analysis per the study timeline and/or client request.

What you will bring to the role

• Excellent communication, planning, and organizational skills.
• Sense of urgency and ability to be adaptable in a fast-paced and rapidly changing environment.
• Self-motivated and excellent problem-solving skills.
• Ability to work independently.
• Ability to negotiate and liaise with clients in a professional manner.
• Must have satisfactory customer service skills.

Your experience

• Bachelor’s Degree (Life Sciences or Health preferred) or 4 years clinical research experience Or Associates Degree with 2 years clinical research experience.
• Min 1 year as a Clinical Research Coordinator preferred