Clinical Research Coordinator
South Portland, Maine
Chest Medicine Associates – Medical/Health Care
Chest Medicine Associates is seeking a part time Clinical Research Coordinator to join our team of compassionate medical professionals. We are a busy medical practice specializing in Critical Care, Pulmonary and Sleep Medicine.
The part time (2 to 3 days per week) Clinical Research Coordinator will work within the Clinical Research Department at Chest Medicine Associates providing professional research study support for specific pulmonary and sleep medicine trial protocols.
This position involves knowledge and ability to follow Good Clinical Practice (GCP) guidelines, FDA regulations, and care and treatment of volunteer clinical trial participants in accordance with specific study protocols. The Coordinator will review research studies requirements and maintain regulatory documents as required.
- The Clinical Research Coordinator will utilize current knowledge of GCP guidelines including protection of clinical trial participants to include conduct of clinical trials.
- Responsible for following protocols, reviewing and adapting informed consent forms for completeness and compliance with regulations.
- Prepare and submit documents to the IRB which includes initial site submission forms, continuing review reports, initial and revised consents, amendments to the protocol, investigator brochures, protocol deviations, SAE reports, and IND safety reports, close-out reports, patients provided documents, such as QOLs, letters, and diaries.
- Prepare and submit to sponsor FDA Form 1572, financial disclosures, CVs and medical licenses.
- The Clinical Research Coordinator will maintain regulatory files (financial disclosures, FDA forms, NCI forms, CVs, medical license, etc.) for clinical trials.
- Monitor trial participant visits by ensuring that all documents are filed and organized. Process a resolution for all previous outstanding regulatory and clinical issues.
- Reviews all signed informed consent forms to assure accuracy.
- Coordinate and prepare for internal, pharmaceutical and external FDA audits.
- Oversee planning, scheduling and implementation of day-to-day clinical activities and procedures
- Assist in recruiting, screening, enrollment and retention of volunteer patients
- Establish data collections systems and procedures to follow research protocols
- The Clinical Research Coordinator will ensure clinical activities are performed in accordance with the protocol and within clinical procedure safety standards
- Dispense investigative product, monitor and record patient response to treatment and communicate study data and results. Maintain source documentation and oversee study activity reports to sponsors and medical, legal and regulatory bodies
- Develop and coordinate maintenance of records on medication dispensation and usage during the study
- Ensure confidentiality of patient records and data that is HIPAA compliant
- Coordinate research work with other CRC staff engaged in study activities at CMA
- 1 year of clinical experience in a healthcare setting required
- Clinical research experience preferred
- GCP certification required (CITI or equivalent) or the ability to obtain GCP certification within 30 days of employment
- Pulmonary and sleep experience desirable but not required.
- Must be extremely detail oriented.
- Ability to communicate effectively with patients, physicians and staff
- PTO is prorated based on the part time hours worked
- Holiday pay for scheduled days worked
- Participation in the 401(k) and Profit-Sharing Plan after eligibility
No phone calls, recruiters, or walk-ins please.
Chest Medicine Associates is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.