Primary duties/responsibilities:The Clinical Operations Assistant responsibilities include, but may not be limited to:Assisting with the initiation, completion, management, and archiving of legal and financial documents for the clinical programs, such as non-disclosure agreements, new vendor requests, vendor contracts, and purchase orders. Managing clinical trial insurance requests, distributing insurance policies and certificates, tracking insurance expiry dates, initiating extensions for expi... more details
Job Description Summary:
The Clinical Operations Assistant provides administrative and project support to the Clinical Operations organization. This includes, but may not be limited to, proactively and independently identifying, coordinating, and monitoring the administrative aspects of the departments’ projects/programs and interacting with key stakeholders as necessary; identifying and implementing/supporting administrative systems, processes and procedures; and completing varied routine, ad-hoc and project-driven administrative tasks as assigned.
The Clinical Operations Assistant supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
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Job Description:
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
The Clinical Operations Assistant responsibilities include, but may not be limited to:
- Assisting with the initiation, completion, management, and archiving of legal and financial documents for the clinical programs, such as non-disclosure agreements, new vendor requests, vendor contracts, and purchase orders.
- Managing clinical trial insurance requests, distributing insurance policies and certificates, tracking insurance expiry dates, initiating extensions for expiring policies, and processing certificates for clinical programs.
- Assisting in organizing and preparing departmental meetings and, when required, clinical program meetings such as investigator meetings.
- Entering investigator information into Encompass system as required.
- Supporting the Protocol Review Committee by scheduling meetings, distributing meeting materials, and documenting meeting minutes.
- Providing general administrative support to the department and study teams by formatting documents, assisting in signature collection, creating meeting materials, managing department electronic mailboxes, helping with study document translation requests, and supporting the department as needed.
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* Minimum level of education and years of relevant work experience.
- Associate’s degree and minimum of 3 years of related professional experience OR a Bachelor’s Degree and a minimum of 1 year of relevant experience in in a pharmaceutical, biotechnology, CRO, university medical center or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
- Experience supporting large departments/groups in a fast-paced, dynamic, multicultural, international environment.
- Demonstrated proficiency using the advanced functionality of Microsoft Office (Power Point, Excel and Word).
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Ability to handle confidential information with discretion.
- Flexibility to work outside of core business hours when necessary.
- Embraces new challenges or changed priorities and adjusts plans and priorities accordingly.
- Experience working in a small but fast growing, entrepreneurial environment.
*Special knowledge or skills and/or licenses or certificates preferred.
- Experience providing support for the administrative tasks associated with a clinical research/clinical operations function.
- Experience with contract management software (i.e., Contracts 365) and service procurement systems (i.e., SAP Ariba).
* Travel requirements
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EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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