Clinical Trial Associate

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Mar 29, 2023

View more

Discipline
Life Sciences, Biotechnology
Organization Type
Pharma

Job Details

Primary Duties:

The clinical trial associate is responsible for providing broad support for clinical trial management. S/he will assist the clinical project managers and other members of the team with day to day clinical trial execution and maintenance activities. This role will be responsible to ensure proper tracking and maintenance of clinical trial data. This role contributes to the overall compliance and completeness of clinical files. This role provides extensive clinical trial administrative support to the Clinical Operations team, to ensure efficient and effective conduct of clinical trials, in compliance with SOPs, policies and local regulatory requirements. This role is expected to take initiative and to propose solutions to problems as they arise, proactively proposes process improvement, SOPs, policies, guidelines, and focus on continuous improvement of clinical trial processes.

Responsibilities:

Clinical trial support:

ensure study documents are tracked, file, maintained, and archived in audit ready condition; maintain clinical trial master files and clinical trial management system (CTMS) tracking throughout the course of the study according to departmental SOPs and ICH-GCP

manage the collection, submission and review of important trial related documents

support translations of study related documents where applicable

manage user access for clinical trial related systems maintain and disseminate study contact lists and trackers

assist as needed with site selection activities

maintain working relationship with investigators, staff, CROs and vendors Job Description Template 2 TO BE COMPLETED BY HIRING MANAGER

assist Clinical Operations team in ensuring sponsor oversight of CROs and vendors

assist with processing and tracking of study and vendor budgets.

ensure timely processing and tracking of invoices and payments and liaising with Finance when necessary

assist with managing queries from sites and provide site support as needed

prepare materials and obtain documents to assist sites with IRB/IBC submissions

develops and maintains study-specific forms and files; assists with clinical document generation, review and revisions

provide initial quality control (QC) of operational data

assist with clinical compliance to SOPs, procedures and regulatory requirements by actively requesting and completing required forms and documents

facilitate written and verbal study communication to internal program team/functions, CROS, vendors, site personnel, and consultants

attend study team, development/strategy team and departmental meetings; support the organization of study specific meetings

assist project managers/teams as needed

assist with quality assurance audits

assist with logistics for vendor meetings, site meetings, etc.

post and maintain study-related information on external information sources (eg, websites) as necessary

assist with clinical supply documentation, ordering, management, and tracking participate in departmental initiatives as requested

Education and Experience Requirements:

Bachelor’s degree in a scientific discipline or equivalent nursing degree required.

Familiarity with the pharmaceutical industry, clinical research, and/or clinical trials is desirable

Proficient in Microsoft Office applications

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.


Nearest Major Market: Philadelphia



Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.

Learn more about Spark Therapeutics and view other openings.

Company

Learn more about this company

Visit this company’s hub to learn about their values, culture, and latest jobs.

Visit employer hub

Learn more about this company

Visit this company’s hub to learn about their values, culture, and latest jobs.

Visit employer hub

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert