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 Sr. 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; and 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, 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, 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. Excellent interpersonal and organizational skills, ability to develop important relationships with key stakeholders, 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, 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.

• 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 Companys 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.