At Constellation we know that our success as a company lies in the hands of individual employees across every element of our company working together. To foster this success, we strive to create a diverse, challenging, exciting, and fun work environment for all employees. We believe that each team member has the ability to impact and improve the lives of patients. We are #BrighterTogether.
We are adding to our clinical team. The Clinical Coordinator will assist with daily clinical trial execution, including the management of CRO activities. You will also aid in the coordination of documentation associated with the conduct of investigational clinical studies in accordance with Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.
How you will spend your day:
- Collect, distribute, track and file trial information – correspondence, clinical documents and clinical trial agreements.
- Coordinate and manage version control of clinical documents. Assist with review and internal quality checks.
- Prepare and distribute copies of finalized protocol and study documents to vendors and internal team members as appropriate.
- Assist with Sponsor oversight of the eTMF; prepare and archive study documentation and accompanying checklists, as necessary.
- Assist with tracking patient samples and reconciliation of clinical supply shipments, including tracking IP requests, logging shipping information and filing Regulatory Documentation Packages.
- Act as secondary operations contact for vendors. Respond to various inquiries from CRO and Clinical Department by providing information according to status or directing calls to the appropriate person. May be required to periodically act as liaison between vendors and other departments.
- Schedule and coordinate study meetings, materials, agendas; track action items.
- Identify and resolve administrative issues.
Key things about you:
- BS/BA degree or equivalent and 1+ year experience in clinical operations.
- Knowledge of 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 Good Clinical Practice (GCP) and the Code of Federal Regulations is required. A broad understanding of essential study documentation is preferred.
- Experience with eTMF.
- Strong communication and interpersonal/team skills.
- Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project is a plus but not required.
- 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, excellent organizational skills, detail oriented, proven effectiveness in a quick-changing environment, excellent people skills, and a proven record as a team player.
We are an Equal Opportunity Employer, a participant in E-Verify and offer great benefits including all the usual important stuff, paid parking or commuter pass, flexibility, generous time off, a plethora of your favorite snacks and deeply discounted access to Cambridge Athletic Club, located in our building.
Constellation Pharmaceuticals is an Equal Opportunity Employer, a participant in E-Verify and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.