Associate Site Manager – Oncology

This is a fully remote position, open to applicants in Connecticut, +10 more states.

📋 Description

• Act as the main point of contact between the Sponsor and the Investigational Site.

• Ensure readiness for inspections by adhering to protocols, SOPs, GCP, regulations, and guidelines from the beginning of the study until site closure.

• Support site selection, qualification evaluation, recruitment and retention strategies, initiation, monitoring, and close-out processes.

• Collaborate with the Local Trial Manager, Clinical Trial Assistant, and Trial Delivery Leader for effective site management.

• Serve as the primary local contact for assigned trial sites.

• Engage in site feasibility assessments, Site Qualification Visits, and investigator meetings.

• Carry out activities related to site initiation, start-up, monitoring, remote oversight, site management, and closure.

• Apply analytical risk-based monitoring techniques and address any monitoring challenges.

• Guarantee proper training for site staff and maintain accurate training records.

• Work together with the central study team to ensure efficient site activation.

• Assist in developing recruitment strategies and contingency plans.

• Ensure sufficient study supplies and proper handling, storage, inventory management, and disposal of clinical drug supplies.

• Maintain prompt data entry, resolve queries, and ensure the accuracy, validity, and completeness of site data.

• Ensure timely reporting and documentation of adverse events, serious adverse events, and product quality complaints.

• Keep trial data and essential documents organized in relevant systems.

• Document trial activities, prepare visit reports and follow-up letters, and communicate status updates and issues.

• Review study files to confirm that archiving requirements are fulfilled.

• Collaborate in documenting and reporting site/study progress.

• Attend team meetings and training sessions, providing feedback or leadership when needed.

• Act as a local expert in assigned protocols and enhance therapeutic knowledge.

• Assist in completing CAPA for audits and site quality concerns.

• Prepare sites for close-out and conduct final close-out visits.

• Monitor site-level expenses and ensure timely payments when necessary.

• Foster relationships with investigators, trial coordinators, site personnel, and other stakeholders.

• Participate in Health Authority and IEC/IRB submissions and notifications as required.

• Contribute to process enhancements and training initiatives.

⛳️ Requirements

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related scientific field.

• At least 1 year of experience in clinical trial monitoring.

• Basic understanding of GCPs, company SOPs, local laws and regulations, assigned protocols, and protocol-specific procedures.

• Proficient computer skills in relevant software applications and clinical systems.

• Strong verbal and written communication abilities.

• Willingness to travel up to 60%, including overnight stays away from home.

• A valid driver’s license from one of the 50 United States and a clean driving record.

• Experience in the oncology therapeutic area is preferred.

• Experience with Phase II and Phase III clinical trials is preferred.

🏝️ Benefits

• Retirement plan (pension).

• Savings plan (401(k)).

• Eligibility for the Company’s long-term incentive program.

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year.

• Holiday pay, including Floating Holidays – 13 days per calendar year.

• Work, Personal and Family Time – up to 40 hours per calendar year.

• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.

• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.

• Caregiver Leave – 80 hours in a 52-week rolling period.

• Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.