Clinical Study Associate

Aequor; Basking Ridge (NJ); On-site; USD 55,000 - 75,000; Full time

Job summary

A healthcare solutions company in Basking Ridge, NJ is looking for a Clinical Study Associate I to assist in clinical study planning and execution. Candidates should have at least 1 year of relevant experience, including familiarity with Veeva. The position involves providing support to study teams, maintaining clinical study documents, and tracking various study metrics. This contract position may extend beyond Feb 2027, requiring on-site presence 1-4 times a week.

Qualifications

• Minimum of 1-year relevant experience required.
• Veeva experience and Oncology experience are a plus.
• Basic oral and written communication skills.

Responsibilities

• Assist in planning and execution of clinical studies under supervision.
• Provide clinical administrative support to study teams.
• Track study metrics and maintain spreadsheets.

Skills

Clinical or basic research

Communication skills

Computer applications proficiency

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Veeva

Job description

Job Title- Clinical Study Associate I / Band B

Location: Basking Ridge, NJ 07920 (On-site)

Duration: Contract till Feb 2027 with possibility to extend

Job id- 36748118

Responsibilities

Job Title: Clinical Study Associate I / Band B Job Schedule: Candidate must be able to come onsite to Basking Ridge, NJ office 1-4 times a week. Assist in planning and execution of clinical studies, under the close supervision of a Senior Manager (or above) within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical administrative support to study teams and on interacting with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with *** (DS) Quality Oversight measures. Support and assist the transmittal of trial and site level document to the DS Document Control Center (DCC) in support of the Trial master File (TMF). Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the supervisor. Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov). Works with Insurance Brokers to obtain study site Insurance Under the guidance of the supervisor, analyze site metrics reports to identify potential areas of concern and bring to supervisor’s attention. Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to the supervisor. Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).

Qualifications

Minimum of 1-year relevant experience is required. Veeva experience is a plus. Oncology experience is a plus. Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO). Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook. Basic oral and written communication skills.

Contact

Thank You,
Gurpreet Kaur
Aequor Technologies LLC
377 Hoes Lane, Suite 300
Piscataway, NJ 08854
[phone]