Skip to main content

Senior Clinical Research Coordinator


General Scope and Summary

Sage Therapeutics is searching for a resourceful and confident professional to assist with daily interventional clinical trial execution activities. The Senior Clinical Research Coordinator will assist in the coordination of documentation associated with the conduct of interventional clinical trials in accordance with Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP), and Sage standard operating policies and procedures.

Roles and Responsibilities

  • Collect trial information and disseminate it to the internal project team, the Contract Research Organization (CRO), and consultants.

  • Coordinate clinical trial correspondence and study and subject newsletters; ensure that clinical trial documents are prepared and maintained per Sage Standard Operating Procedures (SOPs) and GCP requirements.

  • Schedule and coordinate study meetings, prepare meeting materials and agendas, and record and disseminate meeting decisions and actions.

  • Assemble data and complete routine analyses for a variety of reports. Enter data to records or logs and establish and maintain files.

  • Maintain secure study files, including electronic Trial Master File (eTMF) maintenance and oversight; prepare for archiving of study documentation and accompanying checklists.

  • Coordinate and manage version control of clinical documents.

  • Provide customer service to investigative sites; contact sites regarding study issues. Respond to various inquiries from patients, physicians, telephone callers, and visitors by providing information according to guidelines or directing calls to the appropriate person. May be required to act as liaison between investigational sites/vendors and department management.

  • Assist in the follow-up and expedition of Clinical Study Agreements (CSAs); initiate and/or track confidentiality agreements.

  • Prepare distribution of copies of finalized protocol and study documents. Assemble investigator and pharmacy manuals.

  • Assist in the review and approval of Essential (Regulatory) Documentation packages in support of investigative site activation and clinical supply shipments.

  • Assist in the coordination of clinical trial shipments.

  • Provide guidance and training to new administrative staff.

  • Develop and maintain investigator/site contact database.

  • Assist Study Manager with reference searches in support of protocol development.

  • Assist Study Manager with data reviews.

  • Identify and resolve administrative project issues.

  • Track IND safety letter issuance, distribution, and notification of site IRBs/ethics committees.

  • Assist in the resolution of internal and external regulatory authority audit findings.

  • Participate in Pre-Study Visits, Interim Monitoring Visits, and Site Initiation Visits, as appropriate.

  • Co-monitor with Study Manager or designee.

  • Assist in drafting the Sponsor Oversight Plan and Protocol Deviation Plan.

  • May assist in the creation and updating of standardized clinical trial tools and processes and SOPs.

  • Minimal travel required.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal and organizational skills, the ability to develop important relationships with key stakeholders, and good conflict management and negotiation skills.

Basic Qualifications

  • BS/BA degree or equivalent.

  • 2+ years of pharmaceutical or biotechnology industry experience, or equivalent.

Preferred Qualifications

  • Knowledge of drug development as well as clinical operation processes and documentation, including study start up procedures, maintenance phase, and study close out procedures.

  • Knowledge of ICH/GCP and regulatory environments, including regulatory documentation review and approval.

  • Knowledge and implementation of the processes involved in clinical studies following GCP and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical.

  • Experience with eTMF; ability to directly apply essential document knowledge to file documents accordingly based on the DIA reference model.

  • Experience in CNS/Neurology preferred.

  • Established ability to prioritize and manage multiple tasks simultaneously; demonstrated ability to identify and resolve issues and effectively manage timelines.

  • Strong initiative and a can-do attitude. Proven record as a team player.

  • Proficient in MS Excel, Word, and PowerPoint. Knowledge of MS Project preferred.

  • Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

  • Excitement about the vision and mission of Sage.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.

Benefits and Compensation

The base salary hiring range for this position is $78,750 - $108,281.*

  • The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
  • This position is eligible to participate in the Company’s annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
  • To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.
*Base salary ranges are periodically reviewed and subject to change.

Job ID: R001972

#Biotechnology #Careers #ThisIsSage

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.  Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.


Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

EEO is the Law

EEO is the Law - Supplement

Pay Transparency Nondiscrimination

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.

Employment applications

Employment applications are processed through a website that is not owned or controlled by Sage Therapeutics, Inc. Sage Therapeutics, Inc. makes no representation as to the accuracy of the information contained on websites it does not own or control. Sage Therapeutics, Inc. does not recommend and does not endorse the content of any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.


Related Jobs

Medical Science Consultant

  • Consultants
  • US - Remote

Associate Director, HEOR

  • Health Economics & Outcome Research
  • US - Remote

Director, Regulatory Affairs

  • Regulatory Affairs
  • US - Remote