• Login / Signup
    • Instagram
    youtube
    Facebook

    Senior Clinical Research Associate

    Parexel
    1-3 years
    Not Disclosed
    Remote
    10 July 19, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Clinical Research Associate

    Company Overview: At Parexel, we share a unified goal—to improve the world's health. From clinical trials to regulatory, consulting, and market access, every solution we provide is underpinned by a deep conviction in our mission. Every team member contributes to developing therapies that benefit patients. Our work is personal, empathetic, and committed to making a difference.

    Position: Clinical Research Associate Location: Northeast Experience: 1-3 Years

    Roles and Responsibilities:

    Start-up Phase:

    • Serve as Parexel’s primary contact with clinical sites, managing site quality and delivery from site identification through pre-initiation.
    • Develop and maintain relationships with investigators and site staff.
    • Conduct and manage feasibility, site pre-qualification, and qualification activities.
    • Prepare, negotiate, and facilitate execution of Confidentiality Agreements (CDA) and Clinical Site Agreements (CSA).
    • Perform remote Qualification Visits (QVs) and generate visit/contact reports.
    • Develop and approve high-quality country-specific and/or site-specific documents.
    • Prepare and submit IRB/IEC and MoH/RA applications, resolving conflicts and ensuring receipt of final approvals.
    • Update Clinical Trial Management Systems (CTMS) and maintain site documentation.
    • Forecast, develop, and manage plans for IRB/IEC submission, site activation, and patient recruitment.
    • Address site issues and escalate as necessary, including activation timelines and recruitment strategies.

    Maintenance Phase:

    • Act as the direct contact with assigned sites, ensuring study implementation and protocol adherence.
    • Facilitate site access to study systems and ensure compliance with training requirements.
    • Evaluate and resolve issues related to site staff, documentation, and communication.
    • Monitor data quality and integrity, addressing any potential issues.
    • Conduct on-site visits, including Qualification and Initiation visits.
    • Review and follow-up on site payment status, CRF data entry, query status, and SAEs.
    • Perform site-specific training and facilities assessments as needed.
    • Ensure compliance with ICH-GCP and local regulations.

    Overall Accountabilities:

    • Ensure timely and accurate completion of project goals and update applicable trial management systems.
    • Collaborate with team members to meet project goals and provide efficient project planning.
    • Maintain a positive, results-oriented work environment and build collaborative relationships.
    • Ensure compliance with ICH-GCP guidelines, Parexel SOPs, and study-specific procedures.
    • Develop expertise and become a subject matter expert.
    • Complete additional tasks in a timely manner, including timesheets and expenses.

    Skills:

    • Strong problem-solving and analytical skills.
    • Ability to work independently and seek guidance when necessary.
    • Excellent presentation and communication skills.
    • Client-focused approach with the ability to prioritize multiple tasks and meet deadlines.
    • Strong computer skills, including knowledge of CTMS, EDMS, and MS Office.
    • Ability to work across cultures and in a virtual team environment.
    • Proven ability to mentor and support team members.

    Knowledge and Experience:

    • Substantial site management or clinical research experience.
    • Understanding of clinical trials methodology and terminology.

    Education:

    • Degree in biological science, pharmacy, or other health-related disciplines preferred, or equivalent nursing qualification or experience.

    EEO Disclaimer: Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    Latest Jobs

    Medical Science Liaison - Mid-Atlantic Territory

    Teva Pharmaceuticals
    Washington

    Cra Ii - Must Have Neurology Expereince - Sponsor Dedicated - Bulgaria (Homebased)

    Syneos Health
    Remote, USA

    Local Qualified Person For Pharmacovigilance (Qppv) Freelancer - Talent Pool

    Parexel
    Remote, USA

    Medical Sales Representative, Jaksel - Tangerang

    Teva Pharmaceuticals
    Jakarta

    Sr Argus Systems Specialist

    Syneos Health
    Remote, USA

    Medical Information And Adverse Event Intake Specialist With Danish Language

    Iqvia
    Remote, USA

    Medical Information And Adverse Event Intake Specialist With Hungarian And English Language

    Iqvia
    Budapest

    Pharmacovigilance Local Contact Person With Hungarian And English Language

    Iqvia
    Budapest

    Manager, Pharmacovigilance

    Icon
    Remote, USA

    Bilingual Medical Science Liaison

    Teva Pharmaceuticals
    Montreal

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

    Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |

    Maharashtra :

    Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |

    PAN-India :

    Panjab :

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Jaipur | Pilani | Udaipur |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Wrangell |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |

    California :

    Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Storrs |

    D.C :

    Washington |

    Florida :

    Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Rockville |

    Massachusetts :

    Boston | Cambridge | Medford and Somerville | Rockland |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New York :

    Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |

    North Carolina :

    Concord |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |

    Ohio :

    Columbus, |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

    Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |

    Portugal :

    Lisbon |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Goldendale | Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Wyoming :

    Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Denmark :

    Copenhagen |

    Hungary :

    Budapest |

    Istanbul :

    Turkey |

    Serbia :

    Belgrade |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Pharma Jobs in Australia & Canada & Colombia & Croatia & Egypt & England & Indonesia & Ireland & Israel & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Quebec :

    Montreal |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Harlow | London | Salt Lake City |

    Jakarta :

    Jakarta |

    Republic of Ireland :

    Dublin | Limerick |

    Israel :

    Kfar Saba | Netanya | Tel Aviv |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Remote :

    Remote | Remote - Europe | Switzerland | Remote, USA |

    Makkah :

    Rabigh | Khulais | Jeddah | Najran | Riyadh |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |