Sr. Clinical Trial Coordinator/ Clinical Trial Coordinator

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's two lead programs in clinical development are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Pociredir, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies, including beta-thalassemia. The company's proprietary product engine, FulcrumSeekTM, identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression.

Description

We are seeking a highly motivated individual to join our team as a Clinical Trial Coordinator/Senior Clinical Trial Coordinator to maintain and coordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). This is a fantastic opportunity to join Fulcrum as a key member of the clinical operations team, supporting multiple clinical research studies that are aiming to patients without any other options. This individual will partner across the team and facilitate operational efficiencies in clinical trials, guided by SOPs and ICH-GCP.

Responsibilities

• Responsible for the execution of assigned logistical and tactical aspects of Clinical Trials across several regions and range of study phases and Therapeutic Area's

• Executes trial management activities by engaging internal and external team members to support study planning, start up, conduct, and closure of assigned clinical trials

• Assist with maintenance of the internal and external Trial Master Files (TMF); supports the cross-functional team with collection, filing, and tracking and QC of TMF documents to ensure inspection readiness

• Draft, review, and update TMF plan in partnership with CRO and functional leads. Collaborate with Clinical Operations colleagues to ensure consistency in TMF mapping as appropriate.

• Create and maintain clear trackers of trial progress trackers using agreed upon standards and KPIs

• Support the management of clinical trial supplies and sample tracking, management

• Balance competing and evolving priorities across trials.

• Support the vendor and CRO selection process

• Assist in the planning and preparation for internal/external meetings (e.g. CRO Face-to-face meetings, investigator meetings, conferences).

• Responsible for management and oversight of deliverables for assigned CRO and other key external vendors; review and track clinical trial regulatory documents in coordination with the CRO. Depending on experience, might manage vendors with some oversight from the study lead or independently.

• Assist with tracking vendor invoices and internal approvals.

• Support Clinical Operations team in conduct of study team meetings through drafting agendas, meeting minutes, and managing meeting logistics (meeting room, calendar invites).

• Assist the Clinical Operations lead with the preparation and development of critical study documents (e.g. study manuals, study plans, study materials, study newsletters, study templates etc.)

• Assist the Clinical Operations team with preparing study updates for internal and external stakeholders.

• Assist the Clinical Operations team with oversight of study team roster maintenance and vendor contact lists, and managing internal study-specific team training

• Partner with Clinical Operations lead and CRO to develop and maintain study dashboards, study deliverable trackers, team roster and training tracker, study materials, study templates, and patient-facing materials

• Review site specific consent forms, gather functional review and approval as appropriate.

• Actively participate and contribute ideas in the development of department initiatives and goals.

• Support the review and development of clinical operations SOPs, work instructions, systems and processes to ensure consistency and compliance with regulatory standards and guidance

• Other duties as assigned

Qualifications

• BS / MS or equivalent in life sciences preferably

• 2-3 years' experience in clinical research at a hospital, CRO, or biopharmaceutical company is required

• Superior understanding of Microsoft Office

• Aptitude for organizational detail

• Capacity to complete tasks independently in a highly regulated environment

• Strong interpersonal skills and the flexibility to function well within a team environment and within condensed timelines

• Excellent written and verbal communication skills

• Flexibility to function well within a team environment and within condensed timelines

• Ability to adjust to changes in work priorities as required

• Strong interpersonal skills

• Basic understanding of FDA regulatory requirements and good clinical practice (GCP)