Sr. Clinical Research Associate Job at Custom Search Inc., Saint Paul, MN

K00zaGNLNHBNQjZXNlJaMHhDd21kZUdud2c9PQ==
  • Custom Search Inc.
  • Saint Paul, MN

Job Description

Our small start-up client is adding (Sr.) Clinical Research Associates (CRA) to the team. The CRA works as part of the clinical team to ensure the completion of company-sponsored clinical studies. As an internal and externally facing position, this position interacts directly with the internal study team, clinical vendors, clinical Investigators, and other study staff at a clinical research site. The CRA will be the primary contact for the study sites regarding the proper execution of the clinical study.

Your role with the company:

  • May provide study support for one or more clinical studies
  • Execute specific aspects of the clinical study as directed by the CPM and clinical affairs leadership
  • Support the investigator and investigational site selection process
  • Manage the clinical sites within the approved protocol and operating plans
  • Support the development of study operating plans
  • Responsible for site readiness
  • Collaborate with the clinical field team to support adequate enrollment at clinical sites
  • Support the ongoing communication with clinical vendors such as CROs, core labs, or others as designated
  • Support the development of clinical study documents such as protocols, CRFs, training materials, informed consent, operational plans, and required forms
  • Support and or perform remote and/or on-site qualification, initiation, interim, and closeout monitoring visits
  • Responsible for the collection of source documents and associated materials to facility proper safety oversight
  • Support for preparation of materials for independent oversight committees (such as DMC or CEC)
  • On-going review of study data through electronic data capture
  • Tracking and report out of clinical site metrics
  • Identification and escalation of potential patient safety concerns, compliance issues, and other study risks
  • Support ensuring the audit-readiness of the study throughout the study duration

Desired Profile:

  • Bachelor’s degree in life sciences, biological sciences, pharmacy, nursing, biomedical engineering or related field
  • Minimum 2 years clinical research experience in the medical device industry
  • Experience with pre-market IDE clinical trials (Feasibility and Pivotal preferred)
  • Neuromodulation experience preferred
  • Knowledge of good clinical practices, ICH, HIPAA, and other applicable clinical trial-related regulations
  • Familiarity with medical terminology
  • Ability to work both independently and as part of a team
  • Strong communication, interpersonal, and problem-solving skills
  • Excellent organizational and time management skills
  • Proven ability to work in a fast-paced environment
Ability to travel up to 35% primarily within US (average 2x/month)

Job Tags

Interim role,

Similar Jobs

BJC HealthCare

PACU Clinical Nurse PRN Job at BJC HealthCare

 ...Gynecology and Urogynecology , Laparoscopy, Single Port Laparoscopic Procedure, Ear, Nose and Throat, Urology, Oral Maxillofacial, Ophthalmology, Vascular, Plastic Surgery, General Surgery, Gastrointestinal, Colorectal Surgery, THD (Transanal Hemorrhoidal Dearterialization... 

Tracy Volkswagen

IT Manager for Automotive Dealership Group Job at Tracy Volkswagen

 ...IT Manager for Automotive Group Gill Automotive Group is a fast-growing automotive organization, proudly currently serving the Gilroy, Tracy, Madera and Livermore communities in Northern California and the Kailua community in Hawaii. Our team enjoys training programs... 

Glens Falls Center

RN (Pre Operative) Registered Nurse Job at Glens Falls Center

Glens Falls Center is hiring a Registered Nurse (RN) in Glens Falls, NY. Now Offering a $3,000 Sign-On Bonus!!!! DUTIES: As a Registered Nurse (RN), Provide advice & support to the Residents and their families Monitoring Residents and administering...

Johns Hopkins Medicine

Nurse Practitioner or PA - NICU - Main Campus Job at Johns Hopkins Medicine

 ...Bonus to new graduates with NICU experience**NICU Neonatal Nurse Practitioner (NNP) or Neonatal Physician Assistant (PA)Johns Hopkins All...  ...implementing research. The neonatal nurse practitioner or PA works in collaboration with medical, nursing and support services to... 

Pro Residential

Entry Level Leasing Agent Job at Pro Residential

 ...We are looking to IMMEDIATELY HIRE an enthusiastic and motivated Leasing Agent WITH OR WITHOUT EXPERIENCE . Qualifications: Bilingual in Spanish We are looking for experienced and No Experience we will train you. Good communication skills, both verbal...