Specialist II, Study Build - Hyderabad

Overview:

We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

Job Summary:

Prepare and maintain complete and accurate study build material to support the setup and delivery of clinical research studies.

Responsibilities:

Duties/Responsibilities:

• Ensures study build documents are set up in a timely manner so as to not delay study start-up.
• Follows a multi-step procedure to ensure data study build integrity.
• Can work independently day to day and does not require oversight or quality checks from those who are more senior in their current role.
• Ensures that the site-level team is aware when study build is set up and completed at the project level.
• Review and comprehend the protocol and any other supporting material or guidelines.
• Supports new sites in the process of acquisition to ensure harmonization in study build.
• Demonstrates flexibility and willingness to work in multiple systems and manage study build in multiple formats.
• Assist new hires in completing and submitting all required research documentation and training by their deadlines.
• Communicate with site-level staff regarding amendments and changes to study build.
• Communicate internally with the source team regarding source status and changes to study build.
• Adhere to safety and compliance regulations.
• Other duties as assigned.

Qualifications:

Required Skills/Abilities:

• Ensures study build documents are set up in a timely manner so as to not delay study start-up.
• Follows a multi-step procedure to ensure data study build integrity.
• Can work independently day to day and does not require oversight or quality checks from those who are more senior in their current role.
• Ensures that the site-level team is aware when study build is set up and completed at the project level.
• Review and comprehend the protocol and any other supporting material or guidelines.
• Supports new sites in the process of acquisition to ensure harmonization in study build.
• Demonstrates flexibility and willingness to work in multiple systems and manage study build in multiple formats.
• Assist new hires in completing and submitting all required research documentation and trainings by their deadlines.
• Communicate with site-level staff regarding amendments and changes to study build.
• Communicate internally with the source team regarding source status and changes to study build.
• Adhere to safety and compliance regulations.

Education and Experience:

• Bachelor’s degree and 2 years of relevant experience in the life science industry OR
• Associate’s degree with 4 years relevant experience in the life science industry OR
• High School Graduate and/or technical degree with a minimum of 6 years relevant experience in the life science industry
• Certified Clinical Research Professional a plus

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Communicate in person and by telephone.
• Limited walking required.
• Must be able to lift up to 30 pounds at times.

All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.