Marinus Pharmaceuticals, Inc.

Clinical Trial Associate

Location
Villanova Area
Posted
Jun 25, 2018
Required Education
Bachelors Degree
Position Type
Full time

 

Do you want to make a difference?

At Marinus, we are bringing hope to patients by developing new treatments to improve the lives of patients and families affected by epilepsy and neuropsychiatric disorders.  We are comprised of a team of highly qualified individuals committed to developing new therapies for CNS disorders and we are passionate about making a positive difference in the lives of the patients we serve.

We are growing and seeking new team members

 We have multiple clinical programs and are expanding our clinical operations group.  We are seeking Clinical Trial Associates to  support our trials in Pediatric Orphan Indications and Postpartum Depression.  We are in the process of initiating a Phase 3 global study in children with CDKL5 deficiency disorder, a rare genetic epilepsy with no approved therapies. We have studied other disorders that affect pediatric patients such as PCDH19 related epilepsy, Lennox Gastaut Syndrome, and Fragile-X Syndrome, some of which we may consider further studying in the future.

We are currently enrolling patients in our two Phase 2 clinical trials in women with postpartum depression – The Magnolia and Amaryllis Studies.  Post-Partum Depression can affect a mother’s ability to care for her child and negatively affect a child’s cognitive development.  The most common medications prescribed to women who seek treatment for PPD are SSRI’s and SNRI’s which have limited evidence of efficacy.  There are currently no approved therapies to treat PPD.

We provide very competitive compensation and benefits packages.

To learn more about our company please see our website 

http://www.marinuspharma.com/

To apply, please attach your resume in word or a pdf using this format: last name, first initial Director or send to 

HR@marinuspharma.com

Clinical Trial Associate (CTA) operates as the central contact for the clinical study team on designated projects. Assist the clinical study team members with accurately updating and maintaining the clinical systems that track site compliance and performance within project timelines. Participate in the preparation, handling, distribution, review and archiving of clinical documentation and reports; as well as the distribution and tracking of clinical trial supplies. Aids in the planning, conduct, management, and completion of clinical studies through interaction with sites, vendors, sponsors, and team members. and their associated communications and documentation. Assist with accurately updating and maintaining clinical systems; track site compliance and performance within project timelines. Participate in the preparation, handling, distribution, review and archiving of clinical documentation and reports; as well as the distribution and tracking of clinical trial supplies. interaction with sites, vendors, sponsors, and team members. 

 

Roles and Responsibilities:

  • Assist with documents during study start-up including CDAs and CTAs
  • Assist with compilation of regulatory documents
  • Track incoming and outgoing regulatory packages
  • Assist in organization of Investigators' Meetings
  • Assist with patient tracking to document patient visits and overall study progress
  • File essential documents and maintain the TMF
  • Track CRFs
  • Coordinate investigator payments for studies where the Sponsor is responsible for this activity. Verify investigator payment details submitted for payment by CROs for studies where CROs are responsible for this activity
  • Support Clinical department and/or specific CTM with meetings, including preparation of agendas and minutes and tracking action items
  • Distribute trial-related materials to study sites
  • Support preparation and subsequent distribution of newsletters
  • Prepare Study File Notebook for review by study team
  • Create and maintain tracking tools to monitor collection and expiry of essential documents; work with CRO team to obtain required updates
  • Review study files/TMF periodically for accuracy and completeness
  • Assist with essential document reconciliation at study end
  • Assists with tracking study metrics including patient screening and enrollment, data entry, query resolution, etc. optimize the vendor reporting
  • Provides administrative support for study team members including courier shipments, photocopying, telephone coverage, organization of meetings and teleconferences, generation of meeting minutes
  • As directed by Clinical Trial Manager, may directly facilitate resolution of study related issues through communication with investigator site personnel, clinical trial vendors including central laboratories, CROs, etc.
  • May assist Clinical Trial Manager in coordination of payments to clinical sites and vendors

Key Skills

 

  • General knowledge of pharmaceutical research industry
  • Ability to think critically, identify root causes, and formulate potential solutions proactively
  • Well organized and capable of managing multiple tasks with respect to priorities.
  • Excellent verbal and written skills
  • Ability to deal effectively with all levels of management
  • Able to resolve conflicts in a diplomatic manner
  • Solid grasp of MS PowerPoint, Word, Excel and Project
  • Can locate information quickly and resourcefully
  • Self-motivated and able to function with little supervision
  • Highly detail-oriented
  • Strong team member

Requirements:

 

  • BS or BA required
  • 1-3 years demonstrated experience supporting clinical trial operations involving multiple projects

Marinus is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.