Clinical Development Intern

Clinical Development Intern
 

Primary Function

The Clinical Development Intern will serve in an assistant capacity to the Clinical Affairs and Clinical Science departments with a specific focus on clinical trial operations, clinical trial documentation, and assisting with clinical science deliverables. The intern will be exposed to inner workings of the clinical programs in a few different functional capacities. 

Essential Job Functions/Duties

• Assist with Clinical program operations and support trial management team. 
• Assist with the OPD program; more specifically, managing clinical site supplies, tracking metrics, assisting with internal and external communications, preparation of meeting agendas and meeting minutes.
• Assist with the Fortrea program events; more specifically, managing supplies, managing travel/food event requests, tracking metrics, assisting with internal and external team communications, and helping to reconcile invoices.
• Manage the process of filing clinical trial documentation in Microsoft Teams and the Clinical Affairs Fileshare (TMF).
• Assist with Clinical Science deliverables and support the Clinical Scientists with their projects
• Support with retrieving, summarizing and cataloging manuscripts as needed
• Assist with BLA-readiness initiatives 
   

Knowledge, Skills, and Abilities

Exemplifies Cook MyoSite Core Values 

Maintain regular and punctual attendance 

Must maintain company quality and safety standards 

This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above. 

Ability to work in collaborative and independent work situations and environments with minimal supervision 

Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability   

Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals 

Trainability 

Must have effective verbal, written and interpersonal skills 

Able to prioritize and operate proactively 

Must demonstrate critical thinking and proven problem-solving skills 

Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations 

Must be able to multitask  

Computer, Technology, and Technical Skills & Abilities

Proficient knowledge of Microsoft Office software, and other general office equipment. 
 

Education/Qualification Requirements

Education:

Master’s degree in Life Sciences, Health Sciences, or Engineering  

Experience Preferred:

Not Applicable

Preferred Qualifications:

Advanced degree in Life Sciences, Health Sciences or Bioengineering preferred – PhD, PharmD, or MD
 

Physical Requirements/Work Environment

Location:

Full Time Remote

Setting:

General office or home office setting.

Physical Requirements:

Ability to conduct and hear ordinary conversation and telephone communication.

Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.

Ability to work under specific time constraints.

Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.

Visual and manual acuity for working with computers and equipment.

Must be (a) physically capable of operating a motor vehicle on a regular basis, (b) a holder of a valid driver's license, and (c) in good standing to legally operate a motor vehicle.

Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.

Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations.

Travel:

None

Type of Travel:

Not Applicable

Driver’s License Required:

Yes

Passport Required:

No

Option for Visa Sponsored Position:

No Restrictions

Training Compliance:

Employee that interacts with Healthcare Professional:  In addition to below, Compliance with Cook Policy & Guidance On Interaction with Healthcare Professionals.

Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.

At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.

This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.