Senior Clinical Research Associate

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Conduct Site Evaluation Visits, Site Initiation Visits, interim monitoring visits, and Close Out Visits.

• Develop the study reference manual and collaborate with CRO teams, central labs, specialty labs, and vendors to organize study materials.

• Ensure that investigator sites comply with contractual and regulatory standards for site initiation and the initial release of study drugs.

• Assist in formulating study/program plans, including Monitoring Plans, eCRF Completion Guidelines, Data Management Plans, and Safety Management Plans.

• Oversee patient recruitment strategies, recognize recruitment obstacles, and suggest solutions.

• Monitor recruitment progress, data integrity, and patient safety both on-site and remotely via EDC systems and site communication.

• Collaborate with site personnel to guarantee timely and accurate eCRF data entry and query resolution.

• Maintain project documentation and correspondence with investigators/sites.

• Identify and track Serious Adverse Events (SAEs) at study sites.

• Assist with data listing, coding, patient profile reviews, database locking, and site close-out tasks.

• Submit documentation to the Trial Master File promptly.

• Conduct inventory, reconciliation, storage, and security reviews of investigational products.

• Confirm that investigational product dispensing and administration adhere to the study protocol.

• Assess potential issues or risks linked to blinded or randomized investigational-product information.

⛳️ Requirements

• Bachelor's degree in health sciences or a related discipline.

• Over 5 years of experience in monitoring oncology trials.

• Ability to independently perform on-site and remote monitoring visits.

• Exceptional verbal and written communication abilities.

• Strong organizational, multitasking, and time-management skills.

• Proven experience in building and maintaining site relationships and ensuring compliance.

• Familiarity with the International Conference on Harmonization Good Clinical Practice guidelines.

• Proficient in Microsoft Office applications, including Word, Excel, PowerPoint, SharePoint, and Teams.

• Experience with clinical trial systems such as CTMS, EDC, and eTMF.

• Willingness to travel as needed (50–75%).

🏝️ Benefits

• 100% coverage of employee premiums for medical, dental, and vision insurance.

• Short-term disability (STD) benefits.

• Long-term disability (LTD) coverage.

• 401(k) plan with a 50% company match up to 3%.

• A vesting schedule of only 5 years.

• 15 PTO days annually.

• Sick leave provisions.

• 11 paid holidays each year.

• Opportunities for professional learning and growth.

• Chance to make substantial contributions to the success of the company.