Coordinates clinical research studies on human subjects. Responsible for subject recruitment, follow-up, data management, detailed record keeping and regulatory compliance, report writing, and correspondence with investigators, IRBs, and regulatory authorities. Responsible for the new submission of protocols with subsequent amendments. Some participation in protocol writing, and initial and continuing education for Good Clinical Practice compliance.
Minimum Job Requirements
AA/medical/technical school or 3 year of research and/or healthcare experience required
Essential Duties and Responsibilities
Assists Management with Business Development efforts.
Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate.
Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records and coordinating the collection and shipments of specimens as required by protocol.
Communicates study objectives and procedures to all relevant hospital units involved with the study, including the establishment of good rapport with the Principal Investigator and providing him/her with the required assistance.
Communicates with the Sponsor or their representatives, schedules and facilitates study Monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor’s representatives.
Complies with the Hospital’s Research Finance Compliance policies and procedures.
Interacts with patients and families to recruit study subjects and ensures compliance with the protocol.
Responsible for speedy and adequate patient enrollment as determined by the Chief Research Officer in all assigned studies.
Submits new protocols to WIRB and verifies that the proper document was received with the proper MCH format. In addition, submits amendments of protocols to IRB and verifies that the required corrections were inserted following the established procedures.
Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. Follows MCH RI’s Standard Operating Procedures, AAHRPP, HIPPA and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines.
2 years in research experience preferred.
Bilingual in English/Spanish preferred.
Clinical research certification (such as CCRC, CCRP, CRA) and IATA certification preferred.
Excellent communication skills in working with both children and adults.
Experience in pediatric clinical research in a hospital setting preferred.
Good organizational skills, detail-oriented, people-oriented, self-confident, flexible and adaptable to change, with time management skills. High energy level professional.
Knowledge of protocols and its process.
Personal computers, and basic software applications, including word processing, scheduling and contact database, email, web browsing, hospital records, other database software, and office equipment.
Relevant hospital equipment for each clinical trial project.