Clinical Research Coordinator

Medix; Framingham (MA); Sur place; USD 44 000 - 47 000; Plein temps

Résumé du poste

Medix is seeking a Clinical Research Coordinator in Framingham, MA to support clinical trials on a contract-to-hire basis. The role includes participant screening, scheduling and data entry, with oversight of regulatory documents and trial logs.

The ideal candidate will have 2–3 years of clinical research experience, familiarity with GCP/IATA/FDA regulations, and fluent English. Training on protocols, IRB documentation, and trial systems is provided.

Qualifications

• 2–3 years within clinical research.
• College degree in health sciences or significant relevant experience preferred.
• Fluent in written and spoken English.
• Knowledge of GCP, IATA and FDA regulations pertaining to clinical trials.

Responsabilités

• Pre-screen, recruit and schedule participants.
• Complete protocol and trial system training.
• Maintain regulatory documents and study files.
• Obtain informed consent and discuss the study with participants.
• Enter data in the EDC and resolve queries.
• Monitor visits and address issues promptly.
• Manage and report AEs/SAEs and deviations.
• Maintain inventory of study supplies and coordinate payments to participants.
• Ensure regulatory information (IRB docs, disclosures, CVs, trainings) is up to date.

Connaissances

Clinical research

GCP knowledge

IATA knowledge

FDA regulations

Fluent English

Formation

Bachelor's degree in health sciences

Description du poste

Clinical Research Coordinator (259500) Framingham, Massachusetts

Salary: USD32.69 - USD33.65 per hour

Clinical Research Coordinator - Worcester, MA (01701)

Hours: Monday - Friday, normal business hours

Format: contract-to-hire, 6 months

Pay: $32.69 - $33.65/hour

Responsibilities:

• Participant pre-screening, recruitment and scheduling
• Complete protocol and trial system training
• Maintenance of regulatory documents
• Conducts or participates in the informed consent process and discussions with trial participants, including answering any questions related to the study.
• Conducting participant visits
• Entering data in the EDC and resolving all queries
• Updating and maintaining trial logs and participant charts
• Conducting monitoring visits and resolving issues as needed in a timely manner
• Managing and reporting of AEs, SAEs, and deviations
• Maintains adequate inventory of study supplies
• Coordinates appropriate and timely payments to participants
• Manages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsor
• Communicate effectively and professionally with coworkers, leadership, trial participants, sponsors, CROs, and vendors.
• Apply good documentation practices in accordance with ALCOA-C standards when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
• Track screening and enrollment status of patients in site systems and ensure timely communication with patients regarding their study participation
• Understand thoroughly all assigned studies through reading protocols an completing assigned trainings, including preparing for attending site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed
• May set up, train and maintain all technology needed for studies
• Adheres to and supports all Federal regulations and company policies and procedures instituted to safeguard protected health information (PHI)
• Perform other duties as assigned

Required Skills:

• 2 to 3 years within clinical research

Preferred Skills:

• College degree (health sciences) preferred or significant relevant experience
• At least 2 years of CRC experience in a direct patient care role
• Knowledge of Good Clinical Practice (GCP), IATA and FDA regulations pertaining to clinical trials
• Fluent in written and spoken English