Clinical Trial Associate/Coordinator in Cambridge, MA at Apex Life Sciences

Date Posted: 10/31/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Cambridge, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    10/31/2018
  • Job ID:
    901330

Job Description


Clinical Trial Associate, 901330

Job Scope & Purpose:

Our client, a growing company with 4 promising programs in development using gene therapy for rare conditions, is offering an opportunity to step in as a Clinical Trial Associate and support the clinical efforts while learning and growing amongst high caliber professionals. 

Primary Job Responsibilities:

  • Assists the Study Team across all investigator sites and ensures compliance with protocol and overall clinical objectives.
  • Performs project/study management related responsibilities by coordinating and tracking activities for clinical trials in compliance with protocol, Standard Operating Procedures (SOPs) and regulatory guidelines from the inception of the protocol through database lock process. This involves working closely with all functional areas as well as external providers to ensure consistent high-quality study outcomes.
  • Throughout the study, ensures that study activities are executed according to the study protocol, regulatory guidelines, and operational plan.
  • Reviews Investigational Drug Brochures (IDB), Protocols, Case Report Forms (CRFs), and informed consent forms (ICFs) for a thorough understanding of the study drug and procedures.
  • Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
  • Participates in study start-up, conduct, and closeout activities.
  • Assists with the preparation of vendor requests for proposals, and tracks receipt of proposals, MSAs, and SOWs
  • Drafts and/or assists with the preparation of trial-related documents, tools, and templates (start-up forms, screening scripts, source documents, study logs).
  • Supports project management activities including taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites, and maintaining study status trackers.
  • Assists with the preparation and distribution of investigator site contracts and budgets.
  • Maintains the Trial Master File for all clinical projects.

Primary Job Requirements:

  • BS/BA degree in health sciences related field, or RN, or related discipline is required.
  • Excellent written and verbal communication skills.
  • Must have strong PC skills (MS Word, MS Excel, MS Project)
  • Sound analytical and problem-solving skills
  • Ability to act with a consistent sense of urgency with an acute attention to detail
  • Working knowledge and experience with electronic data capture (EDC) systems and CTMS is preferred.
  • Exceptional organizational and time management skills.
  • Ability to multitask and adjust direction based on changing project/corporate priorities.
  • Self-motivated and able to work in a small team environment, able to independently identify tasks/issues that need to be addressed

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us at info@stratacuity.com or 877-787-2821.

Code: ClinOps

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




901330