Sr. Clinical Trial Associate, Clinical Operations

2 weeks ago

Cambridge, United States The Steely Group Full time
Job DescriptionJob Description

Reporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effective implementation and maintenance of the clinical operational study documentation, in accordance with study timelines from study initiation through to study closeout.

Responsibilities:

  • Prepares, processes, distributes, updates and maintains (filing and archiving) clinical study documentation in an electronic format. Ensures study compliance with SOPs and regulatory guidelines. Ensures TMF/eTMF is FDA-inspection ready at all times while the clinical trial is being conducted. Provides access to the systems when applicable.  
  • Creates a documentation system chronicling all incoming/outgoing clinical documentation, maintains study supply documentation, reviews Study Folder regularly to ensure file accuracy and completeness, maintains study specific metric tracking and reviews Clinical Research Associate (CRA) field monitor reports and any necessary follow-up letters in relation to specific Study Monitoring Plan, contacting CROs and CRAs, as required. Provides oversight of Regulatory documents for site activation.
  • Tracks study progress including site contracts, patient enrolment and patient status, and provides QC oversight of the CRO, TMF, QV Reports, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.
  • Contributes to the development and updating of Clinical Operations SOPs and ensuring contribution to Clinical Operations process improvement within the clinical operations team and company in general.
  • Schedules Clinical Operations, study team, investigator and partner meeting, preparing/distributing required materials, and taking and distributing minutes, as required.
  • Contributes to the 3rd party vendor qualification process (e.g. getting their financial condition utilizing a specific vendor, checking if there is an unacceptable risk of bribery or corruption using a specific checklist).
  • Creates and/or reviews the study plans, specification documents, materials, and tools. 
  • Creates and maintains project databases (e.g., contact list, competitive study list), facilitates and tracks study payments following the internal approval process.
  • Processes and tracks payments to vendors and study sites as appropriate. May be required to perform other duties, as assigned.
  • Keeps abreast of the broad context of the industry related to commercial operations, regulations, best practices, relevant technologies and innovations. Understands the implications for the assigned area and implements innovative operations approaches to help ensure efficient operations and achieve mandate.
  • Tracks and ensures training of the study team. 
  • Perform administrative tasks associated with the CTA role and responsibilities, as well as supporting other clinical operations team members.

Requirements / Qualifications:

  • Associate’s Degree, or the equivalent in work experience, preferably in the life sciences.  
  • 3+ years of clinical trial management experience in the pharmaceutical/biotechnology industries, or with a Clinical Research Organizations (CROs) or a clinical research site
  • 1+ years of Clinical Operations work experience. 
  • Knowledge and experience creating, organizing and maintaining eTMFs.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), email and internet.
  • Knowledge of the Pharmaceutical Industry Clinical trial process (clinical trial conduct, documentation and reporting) in accordance with ICH/GCP and other regulatory compliance guidelines.
  • Problem solving capabilities to align with independent assignments requiring limited supervision.
  • Demonstrated ability to effectively manage and problem-solve several complex studies with rigorous timelines; provides high-quality work resulting from attention to detail and accuracy; successfully interacts and communicates with multiple internal and external process owners.
  • Strong verbal and written communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams so as to build commitment.
  • This role may require the incumbent to occasionally travel (domestic) to attend meetings. Travel will be scheduled based upon the needs of the business.
Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.

  • Associate Director, Clinical Operations

    2 weeks ago

    Cambridge, United States Clinical Dynamix, Inc. Full time

    Role: Associate Director, Clinical Operations We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working...

  • Sr. Clinical Trial Associate, Clinical Operations

    4 days ago

    Cambridge, United States The Steely Group Full time

    Reporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effective implementation and maintenance of the clinical operational study documentation, in accordance with study...

  • Sr. Clinical Trial Associate, Clinical Operations

    2 weeks ago

    Cambridge, United States The Steely Group Full time

    Reporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effectiv Clinical, Operations, Clinic, Clinical Research, Associate, Operation, Healthcare, Staffing

  • Senior Clinical Trial Manager

    2 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company Overview Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...

  • Senior Clinical Trial Manager

    2 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company OverviewBoston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...

  • Clinical Trial Assistant

    1 week ago

    Cambridge, United States Scholar Rock Full time

    This role represents a great opportunity to be a part of a growing clinical organization. The Clinical Trial Assistant will support all administrative aspects of study management from start-up through closeout. Responsibilities * Responsible for taking and distributing meeting minutes for both internal and external meetings, in the office and via...

  • Director, Clinical Operations

    2 weeks ago

    Cambridge, United States Foghorn Therapeutics Inc. Full time

    Our Culture: Why work with us? At Foghorn Therapeutics, we believe in "People First, Mission Always." We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics - demonstrated by our community...

  • (Senior) Clinical Trial Assistant

    1 week ago

    Cambridge, United States Merus Full time

    (Senior) Clinical Trial AssistantApplication Deadline: 30 June 2024 Department: Clinical Operations Employment Type: Full Time Location: Cambridge, MA Description The Clinical Operations team is responsible for all clinical trials we conduct for our product candidates. The team has members residing in the US and in the Netherlands. The position is located in...

  • (Senior) Clinical Trial Assistant

    6 days ago

    Cambridge, United States Merus Full time

    (Senior) Clinical Trial AssistantApplication Deadline: 30 June 2024Department: Clinical OperationsEmployment Type: Full TimeLocation: Cambridge, MADescriptionThe Clinical Operations team is responsible for all clinical trials we conduct for our product candidates. The team has members residing in the US and in the Netherlands. The position is located in the...

  • Director, Clinical Operations

    2 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company Overview Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...

  • Director, Clinical Operations

    2 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company OverviewBoston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...

  • Clinical Project Associate

    2 weeks ago

    Cambridge, United States Relay Therapeutics, Inc. Full time

    The Opportunity: As Clinical Project Associate, you will be accountable for providing clinical trial coordination support, along with implementing operational plans in accordance with regulatory guidelines and ICH/GCP standards. You will be an integrated member of the Relay Tx Clinical Development Operations team making key contributions to the execution of...

  • Sr Clinical Research Scientist

    1 week ago

    Cambridge, United States Aequor Full time

    Job DescriptionJob DescriptionWe're looking only for a Senior level Clinical Research Scientist. Location is Hybrid, a minimum of 2 days onsite in Cambridge MA.This role is key to help the medical supervision of clinical studies by Clinical Research Directors (CRD) and to ensure scientific management of clinical studies to be performed by the Clinical &...

  • Associate Director, Clinical Sciences

    6 days ago

    Cambridge, United States BlueRock Therapeutics Full time

    The Associate Director, Clinical Sciences, Ophthalmology will be charged with providing medical and scientific support for BlueRock's Ophthalmology programs. Reporting to the Senior Director, Clinical Development, Ophthalmology, this role will work closely with clinical and program leads as well as other subject matter experts to expand and execute on the...

  • Summer Internship, Clinical Operations

    7 days ago

    Cambridge, United States Beacon Therapeutics (USA) Inc Full time

    Job DescriptionJob DescriptionMissionThe Clinical Operations Summer Intern will be a remote position working on understanding the role of clinical operations in initiating and managing clinical trials within ophthalmology. The intern will be expected to gain operational knowledge regarding current clinical trials at Beacon Therapeutics and apply learnings...

  • Manager/Sr. Manager, Clinical Supply Chain

    5 days ago

    Cambridge, United States Cullinan Therapeutics Full time

    Summary: Cullinan Oncology is seeking an experienced Sr. Manager reporting to the Senior Director of Supply Chain, you will support the planning, creation, implementation, build, and optimization of the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Cullinan's clinical programs. Position Responsibilities: Support the...

  • Senior Director, Clinical Data Management

    3 weeks ago

    Cambridge, United States Editas Medicine Full time

    Job DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....

  • Clinical Monitoring Lead

    2 weeks ago

    Cambridge, United States TalentBurst, Inc. Full time

    Experienced clinical scientist (PharmD, PhD, Nurse, etc..) in clinical development needed to support rare disease clinical trials from protocol development, study start up activities including investigator meetings, working closely with CRO and internal study team to meet study milestones, regulatory form creation and submission, ongoing data review,...

  • IT Operations Coordinator

    7 days ago

    Cambridge, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionClient's Global R&D Discovery IT team is offering a tremendous opportunity for an experienced IT Operations Coordinator to play a vital role in the delivery of technology solutions of value to meet the expanding needs of Client's global IT mission. Come join a growing team and we strive to advance solution delivery to a...

  • Director, Clinical Supply Chain

    4 days ago

    Cambridge, United States QurAlis Full time

    ABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets.  QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with...