Clinical Research Coordinator

CCRM Fertility•Newark, DE

50d

About The Position

The Clinical Research Coordinator will be responsible for organizing and running CCRM clinical and medical research studies. This position reports directly to the Scientific and Genetics Director and should function in an independent fashion, also taking direction from the Senior Clinical Research Coordinator. CCRM is an industry leading pioneer in fertility science, research and advancement, offering access to national network of award-winning physicians, a full suite of fertility services, innovative technology and cutting edge labs. CCRM is currently comprised of eleven locations spanning the U.S. and Canada with growth planned for continued network development on a domestic and international basis.

Requirements

Medical Assistant Certification or LPN licensure.
Graduate of an accredited Medical Assistant School or Graduate of an accredited LPN Program.
Minimum of 2 years of previous medical/research related experience.
Must have excellent computer skills and excellent problem solving skills.
Must be able to appropriately screen research participants for studies.
Strong computer skills, ability to use basic office equipment.
Strong ability to follow procedures and protocols is essential.
Must be organized with a strong ability to multi-task, prioritize, have strong attention to detail, and have a strong ability to utilize time efficiently.
Must have a strong ability to act independently as well as be able to work effectively in a team.
Must have excellent customer service skills, exhibiting courteous, compassionate, and respectful treatment of internal and external customers at all times.
Must consistently display a positive attitude and flexibility in changing situations.
Must have excellent communication skills and make it a priority to consistently communicate positively and professionally with all staff members, physicians and patients.
Must demonstrate the ability to be a team player and possess a willingness to perform duties that are assigned or delegated in a timely manner.
Participate in identifying problems and suggesting solutions.
Maintain confidentiality of all work information.
Maintain strict confidentiality for all patient and clinic information, consistent with established security and confidentiality policies and HIPAA regulation at all times.
Understand and assess for domestic violence and child abuse issues and reporting responsibilities. Will report concerns to Medical Director or Nurse Manager.
Ability to work weekends when needed to meet with patients regarding studies.

Responsibilities

Maintain records of study activity including databases, medical records, and if required, drug dispensation records and regulatory forms.
Assess eligibility of potential subjects through methods such as phone interviews, review of medical records, discussions with physicians and nurses and the weekly ART meeting.
Oversee subject enrollment to ensure that informed consent is properly obtained, documented and scanned into the patient EMR.
Monitor study activities to ensure compliance with protocols and with all relevant institutional policies.
Identify protocol problems or subject complaints, inform Senior Clinical Research Coordinator and assist in problem resolution.
Prepare study-related documentation, such as Institutional Review Board submissions, protocol flow sheets, procedural manuals, adverse event reports, and progress reports.
Liaison with the Institutional Review Board as needed and forward any needed information.
Track enrollment status of subjects and document withdrawal information such as dropout causes.
Coordinate sample collection processes, including patient compliance and communication flow between CCRM, FLC and FG.
Assist the Scientific Director with final study reports, data analysis and manuscript preparation.
Other duties as assigned.