Senior Clinical Trial Specialist

Description of Role

The (contract-to-hire) Sr. Clinical Trial Specialist perform tasks to support the planning and execution of clinical studies across one or more clinical trials. This role is a temporary position with the potential to convert to a permanent role, working closely with the Clinical Trial Manager (CTM) to ensure site start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs), GCP and regulatory guidelines. 

Key Responsibilities

• Assists and provides support to the CTM and study team in the day-to-day operational management of assigned clinical trials.
• Supports the CTM in coordination, preparation, and documentation of internal and external meetings such as Kick-Off Meetings, Investigator Meetings, and vendor management meetings by preparing agendas, minutes, and presentation materials, organizing meeting logistics and travel arrangements if necessary.
• Take responsibility for meeting logistics, agendas, and minutes of the clinical study team in accordance with standards.
• Assist with tracking of purchase orders and invoices, site budgets, investigator payments, CTAs, etc.
• Assists in tracking key site metrics and milestones such as Site Initiation Visits and site activation, subject recruitment and enrollment, critical study dosing days and assessments, scheduled Monitoring Visits and Close-Out Visits etc.
• Contribute to study level tracking by maintaining tools to track assignment and training of study team members, recruitment materials and compliance tools, laboratory kits, samples and study supplies, vendor portal access, etc.
• Support the CTM in the oversight of study vendors; including review of invoices.
• Supports the CTM and contributes to the review of clinical documentation such as Informed Consent (ICF), Study Reference Binder, Study Management Plans, Monitoring plan, study protocols etc.
• Manages and maintains the study team SharePoint
• Assists in clinical site oversite, data entry timeliness, review of monitoring trip reports and tracks resolution of all action items.
• Assists in TMF management to ensure it is being maintained up-to-date and all essential documents are appropriately filed in the TMF.
• Assist CTM and study team in the review and cleaning of study data in preparation for database lock. 

Qualifications

• B.A. or B.S. degree required.
• 4+ year’s experience within a biotech or pharmaceutical organization.
• Experience working with clinical sites, principal investigators, clinical operations staff and CROs a plus. 
• Knowledge and training on Good Clinical Practice (GCP) for clinical research studies.
• Computer skills should include proficiency with Microsoft Office software, specifically, Outlook, Word, and Excel.
• Independently motivated, detail oriented and good problem-solving ability.
• Excellent written and verbal communication skills.
• Flexible and able to adapt to new situations as the business demands.
• Ability to work effectively from a virtual home office setting.
• Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.
• Occasional travel may be required to attend investigator meetings, site visits, and/or professional conferences. Amount of travel required is study-specific.

Compensation

The hourly range for this position is $65.00 to $85.00 per hour. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

Contractors engaged through Centessa are employed through a third-party agency that serves as the employer of record and provides access to a comprehensive benefits package. Eligible contractors may enroll in medical plans, including PPO and EPO options, as well as dental and vision coverage after 30 days. Additionalperks, such as a 401(k), wellness programs, and other discounts, may also be available to eligible contractors. 

Work Location

The Senior Clinical Specialist role is based in the US, with occasional travel.

POSITION: Temporary, non-exempt